Trial Outcomes & Findings for Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma (NCT NCT00923936)
NCT ID: NCT00923936
Last Updated: 2018-07-24
Results Overview
Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) \& noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
6 cycles, an average of 18 weeks
Results posted on
2018-07-24
Participant Flow
Participant milestones
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Overall Study
progressive disease on study
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to follow up
|
2
|
0
|
|
Overall Study
Continuing in follow up period
|
2
|
1
|
Baseline Characteristics
Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma
Baseline characteristics by cohort
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
50.85 years
n=99 Participants
|
40.85 years
n=107 Participants
|
45.95 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 cycles, an average of 18 weeksOverall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) \& noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.
Outcome measures
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.
|
50 percentage of participants
Interval 27.0 to 73.0
|
67 percentage of participants
Interval 33.0 to 91.0
|
SECONDARY outcome
Timeframe: 6 cycles, an average of 18 weeksPopulation: No patients had a complete response.
Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.
Outcome measures
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 32.0
|
SECONDARY outcome
Timeframe: 7 years and 6 months and 21 daysHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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 |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 cycles, an average of 18 weeksResponse was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.
Outcome measures
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Median Number of Cycles Need to Obtain a Partial Response
|
2 Cycles
Interval 1.0 to 6.0
|
4 Cycles
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 monthsParticipants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.
Outcome measures
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 Participants
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 Participants
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Percentage of Participants With 12- Month Progression-free Survival (PFS)
|
44 percentage of participants
Interval 23.0 to 64.0
|
42 percentage of participants
Interval 15.0 to 67.0
|
Adverse Events
KS; Classic or HIV+ Not Improved on Antivirals
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 participants at risk
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 participants at risk
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
Other adverse events
| Measure |
KS; Classic or HIV+ Not Improved on Antivirals
n=10 participants at risk
Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
n=6 participants at risk
All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m\^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
70.0%
7/10 • Number of events 26 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 17 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
80.0%
8/10 • Number of events 28 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 16 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
40.0%
4/10 • Number of events 12 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 38 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.0%
2/10 • Number of events 4 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 26 • 7 years and 6 months and 21 days
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Amylase
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Anal bleeding
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
10.0%
1/10 • Number of events 6 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 26 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
CD4 count
|
50.0%
5/10 • Number of events 9 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 7 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
30.0%
3/10 • Number of events 11 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 15 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
General disorders
Constitutional Symptoms - Other (R leg swelling)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 5 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Creatinine
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 10 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Dental: teeth
|
20.0%
2/10 • Number of events 4 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Skin breakdown
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 7 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Discoloration of Hard Palate
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
30.0%
3/10 • Number of events 4 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 7 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
Edema: limb
|
40.0%
4/10 • Number of events 8 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
5/10 • Number of events 12 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 6 • 7 years and 6 months and 21 days
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Flushing
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Gastrointestinal - Heartburn/dyspepsia
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
40.0%
4/10 • Number of events 11 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 5 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Gum bleeding
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Renal and urinary disorders
Hematuria
|
20.0%
2/10 • Number of events 4 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Hemoglobin
|
70.0%
7/10 • Number of events 21 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 29 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Abdomen NOS
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Hemorrhage, GU::Urinary NOS
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 6 • 7 years and 6 months and 21 days
|
|
Renal and urinary disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
30.0%
3/10 • Number of events 3 • 7 years and 6 months and 21 days
|
66.7%
4/6 • Number of events 17 • 7 years and 6 months and 21 days
|
|
Endocrine disorders
Hot flashes/flushes
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Cardiac disorders
Hypertension
|
40.0%
4/10 • Number of events 8 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Rash:acne/acneiform
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Anal/perianal
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
40.0%
4/10 • Number of events 5 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with unknown ANC::Dental-tooth
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
60.0%
6/10 • Number of events 35 • 7 years and 6 months and 21 days
|
66.7%
4/6 • Number of events 43 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
80.0%
8/10 • Number of events 34 • 7 years and 6 months and 21 days
|
83.3%
5/6 • Number of events 25 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 7 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
50.0%
5/10 • Number of events 6 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Mood alteration::Anxiety
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Mood alteration::Depression
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Stomach
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Aches/Myalgia; Muscle spasm)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 5 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Neck heaviness
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Neurology - Other (Burning smell)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Neuropathy: sensory
|
40.0%
4/10 • Number of events 4 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
5/10 • Number of events 35 • 7 years and 6 months and 21 days
|
66.7%
4/6 • Number of events 42 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Right posterior knee
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Pain::Anus
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
30.0%
3/10 • Number of events 3 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Pain::Head/headache
|
50.0%
5/10 • Number of events 6 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
40.0%
4/10 • Number of events 5 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Pain::Oral-gums
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Pain::Pain NOS
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Pain::Rectum
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain::Tumor pain
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Reproductive system and breast disorders
Pain::Urethra
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Paresthesia
|
20.0%
2/10 • Number of events 3 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Periodontal disease
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
50.0%
5/10 • Number of events 20 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 3 • 7 years and 6 months and 21 days
|
|
Blood and lymphatic system disorders
Platelets
|
60.0%
6/10 • Number of events 21 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
20.0%
2/10 • Number of events 4 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Proteinuria
|
50.0%
5/10 • Number of events 13 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 18 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
30.0%
3/10 • Number of events 3 • 7 years and 6 months and 21 days
|
66.7%
4/6 • Number of events 9 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Renal and urinary disorders
Hemorrhage/Bleeding-Hemorrhage, GU
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Immune system disorders
Rhinorrhea
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Immune system disorders
Runny nose
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 2 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
30.0%
3/10 • Number of events 3 • 7 years and 6 months and 21 days
|
66.7%
4/6 • Number of events 6 • 7 years and 6 months and 21 days
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
30.0%
3/10 • Number of events 3 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
33.3%
2/6 • Number of events 5 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Ulcer, GI::Anus
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Ulcer, GI::Rectum
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
40.0%
4/10 • Number of events 8 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 6 • 7 years and 6 months and 21 days
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Rash: acne/acneform
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Hand-foot Syndrome
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
50.0%
3/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Rash/desquamation
|
20.0%
2/10 • Number of events 2 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Hyperpigmentation
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Dermal change
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-"Urobilinogen" t
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 4 • 7 years and 6 months and 21 days
|
|
Infections and infestations
Infection - Other, Ungual, foot
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue, Other-fasciitis, plantar
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Nasal cavity/paranasal sinus
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Leg
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Left foot
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Left middle finger
|
0.00%
0/10 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Right foot
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Thigh
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
General disorders
Pain - Neck, back, shoulder
|
10.0%
1/10 • Number of events 2 • 7 years and 6 months and 21 days
|
0.00%
0/6 • 7 years and 6 months and 21 days
|
|
Gastrointestinal disorders
Hemorrhage/Bleeding-Hemorrhage, GI
|
10.0%
1/10 • Number of events 1 • 7 years and 6 months and 21 days
|
16.7%
1/6 • Number of events 1 • 7 years and 6 months and 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place