Trial Outcomes & Findings for Atezolizumab With Neoadjuvant Chemotherapy for Patients With Newly-Diagnosed Advanced-Stage Ovarian Cancer (NCT NCT03394885)
NCT ID: NCT03394885
Last Updated: 2021-08-12
Results Overview
The number of subjects able to undergo interval cytoreductive surgery will be utilized as a measure of safety regarding the initial dosing of atezolizumab.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
9 weeks
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Alternative Therapy
|
1
|
Baseline Characteristics
Atezolizumab With Neoadjuvant Chemotherapy for Patients With Newly-Diagnosed Advanced-Stage Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 9 weeksThe number of subjects able to undergo interval cytoreductive surgery will be utilized as a measure of safety regarding the initial dosing of atezolizumab.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Safety: Incidence of Post Chemotherapy Surgical Debulking
|
15 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThe number of adverse events experienced while receiving study drugs will be utilized to assess safety of atezolizumab.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Safety: Incidence of Treatment Emergent Adverse Events
None (Grade 0)
|
1 Participants
|
|
Safety: Incidence of Treatment Emergent Adverse Events
Mild (Grade 1)
|
2 Participants
|
|
Safety: Incidence of Treatment Emergent Adverse Events
Moderate (Grade 2)
|
9 Participants
|
|
Safety: Incidence of Treatment Emergent Adverse Events
Severe (Grade 3)
|
4 Participants
|
|
Safety: Incidence of Treatment Emergent Adverse Events
Life Threatening (Grade 4)
|
2 Participants
|
|
Safety: Incidence of Treatment Emergent Adverse Events
Lethal (Grade 5)
|
0 Participants
|
PRIMARY outcome
Timeframe: Cycles 1-6,18 months totalPopulation: Participants planned to receive atezolizumab at each cycle.
Percentage of planned doses of atezolizumab received at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Safety: Dose Intensity
Cycle 1
|
100.0 percentage of planned doses
|
|
Safety: Dose Intensity
Cycle 2
|
81.3 percentage of planned doses
|
|
Safety: Dose Intensity
Cycle 3
|
93.3 percentage of planned doses
|
|
Safety: Dose Intensity
Cycle 4
|
86.7 percentage of planned doses
|
|
Safety: Dose Intensity
Cycle 5
|
86.7 percentage of planned doses
|
|
Safety: Dose Intensity
Cycle 6
|
100.0 percentage of planned doses
|
PRIMARY outcome
Timeframe: Cycles 1-6,18 months totalPopulation: Participants who received atezolizumab at each cycle.
The number of dose modifications for atezolizumab at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject. Dose modifications are defined as doses delayed, doses discontinued, or doses held.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Safety: Incidence of Dose Modifications
Cycle 1
|
0 dose modifications
|
|
Safety: Incidence of Dose Modifications
Cycle 2
|
3 dose modifications
|
|
Safety: Incidence of Dose Modifications
Cycle 3
|
1 dose modifications
|
|
Safety: Incidence of Dose Modifications
Cycle 4
|
2 dose modifications
|
|
Safety: Incidence of Dose Modifications
Cycle 5
|
3 dose modifications
|
|
Safety: Incidence of Dose Modifications
Cycle 6
|
2 dose modifications
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Five participants were not evaluable for response.
RECIST criteria will be utilized for subjects over the course of the study to measure their response to study drugs. A Complete Response (disappearance of all tumor lesions) or Partial Response (reduction of greater than 30% in total tumor size) is considered a response.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=13 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Number of Participants With a Complete or Partial Response as Measured by RECIST (Response Evaluation Criteria in Solid Tumors)
|
12 Participants
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Three participants were not evaluable for response.
Cytoreduction pathologic complete remission will be measured using RECIST (Response Evaluation Criteria in Solid Tumors) and immune-related response criteria.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=15 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Number of Participants With Pathologic Complete Remission
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsAll patients will be evaluated for progression free survival from the date of first treatment to the date of first observation of progressive disease or death due to any cause or will be stopped at date of last follow-up for those still alive without disease progression. 18-month progression free survival rate as estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Progression Free Survival Rate
|
0.65 proportion of participants
Interval 0.26 to 0.92
|
SECONDARY outcome
Timeframe: 18 monthsAll patients will be evaluated for overall survival from the date of first treatment on protocol to the date of death due to any cause and will be stopped at date of last follow-up for those still alive.18-month overall survival rate as estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Overall Survival Rate
|
0.93 proportion of participants
Interval 0.82 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsAnalyzing changes in PD-L1 expression measured based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing), and progression free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsAnalyzing changes in tumor infiltrating lymphocytes expression based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsAnalyzing changes in immune checkpoint receptor expression based on: flow cytometry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 18 monthsPopulation: Data not collected on 4 participants.
Analyzing changes in cytokine expression based on: ELISA (enzyme-linked immunosorbent assay) after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Outcome measures
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=14 Participants
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Translational: Fold Change in Cytokine Expression
CXCL10 Fold Change
|
0.7 Fold change
Interval 0.2 to 3.8
|
|
Translational: Fold Change in Cytokine Expression
INFgamma Fold Change
|
0.8 Fold change
Interval 0.0 to 6.0
|
|
Translational: Fold Change in Cytokine Expression
IL10 Fold Change
|
0.9 Fold change
Interval 0.2 to 1.5
|
|
Translational: Fold Change in Cytokine Expression
IL12p70 Fold Change
|
1.4 Fold change
Interval 0.0 to 13.5
|
|
Translational: Fold Change in Cytokine Expression
IL1b Fold Change
|
0.9 Fold change
Interval 0.2 to 16.5
|
|
Translational: Fold Change in Cytokine Expression
IL2RA Fold Change
|
1.1 Fold change
Interval 0.4 to 2.8
|
|
Translational: Fold Change in Cytokine Expression
IL6 Fold Change
|
0.4 Fold change
Interval 0.0 to 5.6
|
|
Translational: Fold Change in Cytokine Expression
TNFalpha Fold Change
|
0.8 Fold change
Interval 0.2 to 1.9
|
|
Translational: Fold Change in Cytokine Expression
TIM3 Fold Change
|
1.0 Fold change
Interval 0.6 to 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsAnalyzing changes in gene expression profiles based on: RNA sequencing after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 participants at risk
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Infections and infestations
Infections and infestations - Other: MRSA
|
5.6%
1/18 • 18 months
|
|
Investigations
Neutrophil count decreased
|
5.6%
1/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • 18 months
|
Other adverse events
| Measure |
Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
n=18 participants at risk
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by
2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by
3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).
4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Atezolizumab: 1200mg IV q3weeks
Carboplatin: 5-6mg/ML IV q3 weeks
Paclitaxel: 70-80 mg/m2 IV q1 week
Bevacizumab: 15 mg/kg IV q3 weeks
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.6%
10/18 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
88.9%
16/18 • 18 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • 18 months
|
|
Cardiac disorders
Mitral valve disease
|
5.6%
1/18 • 18 months
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • 18 months
|
|
Cardiac disorders
Sinus tachycardia
|
22.2%
4/18 • 18 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • 18 months
|
|
Endocrine disorders
Hyperthyroidism
|
22.2%
4/18 • 18 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
3/18 • 18 months
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • 18 months
|
|
Eye disorders
Cataract
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
2/18 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
9/18 • 18 months
|
|
Gastrointestinal disorders
Ascites
|
11.1%
2/18 • 18 months
|
|
Gastrointestinal disorders
Bloating
|
16.7%
3/18 • 18 months
|
|
Gastrointestinal disorders
Colonic fistula
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
38.9%
7/18 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
12/18 • 18 months
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
3/18 • 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
3/18 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
3/18 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
12/18 • 18 months
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • 18 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
2/18 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • 18 months
|
|
General disorders
Edema limbs
|
33.3%
6/18 • 18 months
|
|
General disorders
Fatigue
|
83.3%
15/18 • 18 months
|
|
General disorders
Fever
|
5.6%
1/18 • 18 months
|
|
General disorders
Flu like symptoms
|
11.1%
2/18 • 18 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
1/18 • 18 months
|
|
General disorders
Malaise
|
5.6%
1/18 • 18 months
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • 18 months
|
|
General disorders
Pain
|
27.8%
5/18 • 18 months
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Bladder infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Device related infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Eye infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Nail infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Rhinitis infective
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • 18 months
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
2/18 • 18 months
|
|
Infections and infestations
Urinary tract infection
|
22.2%
4/18 • 18 months
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
2/18 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • 18 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
38.9%
7/18 • 18 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.6%
1/18 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
27.8%
5/18 • 18 months
|
|
Investigations
Alkaline phosphatase increased
|
27.8%
5/18 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
9/18 • 18 months
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • 18 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
1/18 • 18 months
|
|
Investigations
CPK increased
|
5.6%
1/18 • 18 months
|
|
Investigations
Creatinine increased
|
11.1%
2/18 • 18 months
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • 18 months
|
|
Investigations
Neutrophil count decreased
|
88.9%
16/18 • 18 months
|
|
Investigations
Platelet count decreased
|
83.3%
15/18 • 18 months
|
|
Investigations
Thyroid stimulating hormone increased
|
16.7%
3/18 • 18 months
|
|
Investigations
Weight gain
|
5.6%
1/18 • 18 months
|
|
Investigations
Weight loss
|
38.9%
7/18 • 18 months
|
|
Investigations
White blood cell decreased
|
72.2%
13/18 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
38.9%
7/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
4/18 • 18 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
5.6%
1/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18 • 18 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.1%
2/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
55.6%
10/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
9/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
55.6%
10/18 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.4%
8/18 • 18 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
6/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.6%
1/18 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • 18 months
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • 18 months
|
|
Nervous system disorders
Dysgeusia
|
27.8%
5/18 • 18 months
|
|
Nervous system disorders
Headache
|
33.3%
6/18 • 18 months
|
|
Nervous system disorders
Hypersomnia
|
5.6%
1/18 • 18 months
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
77.8%
14/18 • 18 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • 18 months
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • 18 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • 18 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • 18 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.6%
1/18 • 18 months
|
|
Renal and urinary disorders
Glucosuria
|
5.6%
1/18 • 18 months
|
|
Renal and urinary disorders
Hematuria
|
11.1%
2/18 • 18 months
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
3/18 • 18 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.6%
1/18 • 18 months
|
|
Renal and urinary disorders
Urinary frequency
|
22.2%
4/18 • 18 months
|
|
Renal and urinary disorders
Urinary urgency
|
5.6%
1/18 • 18 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
11.1%
2/18 • 18 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
1/18 • 18 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
22.2%
4/18 • 18 months
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
5.6%
1/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
27.8%
5/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
55.6%
10/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
6/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
2/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
3/18 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.9%
7/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
38.9%
7/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.4%
8/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
2/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
9/18 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
2/18 • 18 months
|
|
Vascular disorders
Flushing
|
5.6%
1/18 • 18 months
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • 18 months
|
|
Vascular disorders
Hypertension
|
38.9%
7/18 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place