Trial Outcomes & Findings for Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer (NCT NCT01803269)
NCT ID: NCT01803269
Last Updated: 2020-06-26
Results Overview
Time from enrollment to disease progression or death from any cause
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 months
Results posted on
2020-06-26
Participant Flow
Participant milestones
| Measure |
Arm A (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
14
|
|
Overall Study
COMPLETED
|
4
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
Baseline Characteristics
Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.9 years
n=99 Participants
|
68.1 years
n=107 Participants
|
67.3 years
n=206 Participants
|
67.9 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
16 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 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
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
29 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTime from enrollment to disease progression or death from any cause
Outcome measures
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Progression-free Survival
|
1.3 months
Interval 0.5 to 1.8
|
2.1 months
Interval 0.7 to 2.9
|
1.3 months
Interval 0.9 to 2.2
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients initiating treatment (i.e., exclude 3 withdrawals prior to starting treatment).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A (Topotecan Hydrochloride)
n=4 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=7 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=11 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Response Rates According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort A)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 56 daysPopulation: Patients completing two cycles of therapy.
Change in sum of longest diameters of all target lesions from baseline to end of cycle 2.
Outcome measures
| Measure |
Arm A (Topotecan Hydrochloride)
n=2 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=7 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=9 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Continuous Change in Tumor Size.
|
-50.0 mm
Standard Error 42.0
|
16.8 mm
Standard Error 6.1
|
5.1 mm
Standard Error 6.1
|
SECONDARY outcome
Timeframe: Up to 3 yearsTime from enrollment until death from any cause
Outcome measures
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Overall Survival
|
4.0 months
Interval 0.5 to 20.0
|
5.3 months
Interval 2.0 to 12.5
|
2.5 months
Interval 1.2 to 7.3
|
SECONDARY outcome
Timeframe: Up to 3 years after completion of study treatmentAny adverse event regardless of grade or attribution
Outcome measures
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 Participants
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 Participants
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Frequency of Reported Side Effects
|
4 Participants
|
7 Participants
|
12 Participants
|
Adverse Events
Arm A (Topotecan Hydrochloride)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 3 deaths
Arm B (CRLX101)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 8 deaths
Cohort C
Serious events: 5 serious events
Other events: 12 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 participants at risk
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 participants at risk
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 participants at risk
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Death NOS
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Pain
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Fatigue
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Psychiatric disorders
Acute mental status change
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
Other adverse events
| Measure |
Arm A (Topotecan Hydrochloride)
n=7 participants at risk
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
|
Arm B (CRLX101)
n=8 participants at risk
Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cyclodextrin-based polymer-camptothecin CRLX101: Given IV
|
Cohort C
n=14 participants at risk
Non-randomized group that had no response to 1st line therapy or relapse within 60 days after completion of first-line chemotherapy
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • 3 years
|
25.0%
2/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
28.6%
4/14 • 3 years
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 3 years
|
37.5%
3/8 • 3 years
|
35.7%
5/14 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • 3 years
|
25.0%
2/8 • 3 years
|
50.0%
7/14 • 3 years
|
|
General disorders
Edema limbs
|
14.3%
1/7 • 3 years
|
25.0%
2/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
General disorders
Facial pain
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Fatigue
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
57.1%
8/14 • 3 years
|
|
General disorders
Fever
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
35.7%
5/14 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
28.6%
4/14 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • 3 years
|
12.5%
1/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Investigations
White blood cell decreased
|
14.3%
1/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • 3 years
|
37.5%
3/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
28.6%
4/14 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
42.9%
6/14 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
General disorders
Pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/7 • 3 years
|
12.5%
1/8 • 3 years
|
0.00%
0/14 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 3 years
|
25.0%
2/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
General disorders
Chills
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
21.4%
3/14 • 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
14.3%
2/14 • 3 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
|
Investigations
Weight loss
|
0.00%
0/7 • 3 years
|
0.00%
0/8 • 3 years
|
7.1%
1/14 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place