Trial Outcomes & Findings for Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma (NCT NCT00002601)
NCT ID: NCT00002601
Last Updated: 2017-03-03
Results Overview
Criteria for early termination of this feasibility study: \> 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; \> 2 patients experience grade 3 hepatic or gastrointestinal toxicity or \> 3 patients are unable to receive the second cycle of treatment; \> 2 patients experience grade 5 toxicity related to treatment regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 years after completion of treatment
Results posted on
2017-03-03
Participant Flow
Participant milestones
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Baseline characteristics by cohort
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 Participants
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|
|
Age, Continuous
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years after completion of treatmentCriteria for early termination of this feasibility study: \> 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; \> 2 patients experience grade 3 hepatic or gastrointestinal toxicity or \> 3 patients are unable to receive the second cycle of treatment; \> 2 patients experience grade 5 toxicity related to treatment regimen.
Outcome measures
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 Participants
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
Cycle 2
Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|---|
|
Number of Participants With Grade 3 Bilirubin
|
3 participants with Grade 3 Bilirubin
|
—
|
PRIMARY outcome
Timeframe: 2 months after completion of second cycle of treatment.Number of patients with grade 3 and 4 toxicities observed during cycles 1 \& 2 using the Common Toxicity Criteria Version for Chemotherapy.
Outcome measures
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 Participants
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
Cycle 2
n=13 Participants
Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|---|
|
Toxicities Counts
Elevated PTT
|
1 Participants
|
0 Participants
|
|
Toxicities Counts
Anemia
|
8 Participants
|
3 Participants
|
|
Toxicities Counts
Leukopenia
|
13 Participants
|
11 Participants
|
|
Toxicities Counts
Neutropenia
|
13 Participants
|
11 Participants
|
|
Toxicities Counts
Febrile neutropenia
|
13 Participants
|
9 Participants
|
|
Toxicities Counts
Thrombocytopenia
|
13 Participants
|
11 Participants
|
|
Toxicities Counts
Mucositis
|
13 Participants
|
1 Participants
|
|
Toxicities Counts
Bacteremia/sepsis
|
2 Participants
|
4 Participants
|
|
Toxicities Counts
Hyperglycemia
|
5 Participants
|
1 Participants
|
|
Toxicities Counts
Pulmonary function impairment (FEV1)
|
1 Participants
|
0 Participants
|
|
Toxicities Counts
Pulmonary infiltrates
|
0 Participants
|
2 Participants
|
|
Toxicities Counts
Diarrhea
|
1 Participants
|
0 Participants
|
|
Toxicities Counts
Arrhythmia
|
1 Participants
|
1 Participants
|
|
Toxicities Counts
Hematuria
|
1 Participants
|
0 Participants
|
|
Toxicities Counts
Mood
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Until disease progression, up to 5 YearsEstimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 Participants
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
Cycle 2
Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|---|
|
5-year Progression-free Survival
|
23 percentage of participants
Interval 0.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: Until death from any cause, up to 5 yearsEstimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 Participants
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
Cycle 2
Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|---|
|
5-year Overall Survival
|
31 percentage of participants
Interval 14.0 to 70.0
|
—
|
Adverse Events
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 participants at risk
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|
|
Cardiac disorders
Dysrhythmias
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Partial Thromboplastin Time
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
n=13 participants at risk
Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
|
|---|---|
|
Nervous system disorders
Cerebellar
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Clinical (Physical Exam)
|
69.2%
9/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Dysrhythmias
|
46.2%
6/13 • Number of events 8 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Fluid Retention
|
92.3%
12/13 • Number of events 20 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Hemorrhage
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Ischemia
|
53.8%
7/13 • Number of events 10 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Other Misc
|
69.2%
9/13 • Number of events 31 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial
|
53.8%
7/13 • Number of events 10 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
84.6%
11/13 • Number of events 18 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Stomatitis
|
92.3%
12/13 • Number of events 22 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Weight (Food Intake)
|
61.5%
8/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Clinical Coagulation
|
69.2%
9/13 • Number of events 13 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
EF/CHF
|
46.2%
6/13 • Number of events 9 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear disorder
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
13/13 • Number of events 22 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
13/13 • Number of events 23 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
13/13 • Number of events 22 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 10 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever (no infection)
|
84.6%
11/13 • Number of events 18 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Allergy
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AGC
|
92.3%
12/13 • Number of events 22 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline Phosphatase
|
69.2%
9/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Amylase
|
30.8%
4/13 • Number of events 6 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin
|
69.2%
9/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine
|
53.8%
7/13 • Number of events 8 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Fibrinogen
|
15.4%
2/13 • Number of events 3 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Partial Thromboplastin Time
|
53.8%
7/13 • Number of events 11 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets
|
92.3%
12/13 • Number of events 22 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Prothrombin Time
|
69.2%
9/13 • Number of events 13 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
SGOT/SGT
|
69.2%
9/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
WBC
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
13/13 • Number of events 23 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
13/13 • Number of events 23 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
92.3%
12/13 • Number of events 21 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
13/13 • Number of events 23 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Cortical/State of Consciousness
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 2 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
76.9%
10/13 • Number of events 18 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Motor Activity
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral Nervous System Sensory
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Ideation
|
53.8%
7/13 • Number of events 12 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Mood
|
69.2%
9/13 • Number of events 16 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
53.8%
7/13 • Number of events 8 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
53.8%
7/13 • Number of events 8 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
7.7%
1/13 • Number of events 1 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
5/13 • Number of events 8 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Extensive Skin Rash
|
61.5%
8/13 • Number of events 11 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Local Skin Rash
|
61.5%
8/13 • Number of events 11 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
15.4%
2/13 • Number of events 3 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • Number of events 3 • Adverse events collected over a period of 45 months
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place