Trial Outcomes & Findings for Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy (NCT NCT02071901)
NCT ID: NCT02071901
Last Updated: 2021-12-01
Results Overview
Number of participants with a median platelet count \>= 50,000/uL
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Day 24 of Treatment
Results posted on
2021-12-01
Participant Flow
Participant milestones
| Measure |
Supportive Care (Eltrombopag Olamine)
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
Baseline characteristics by cohort
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Age, Continuous
|
67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 24 of TreatmentPopulation: Participants who completed study
Number of participants with a median platelet count \>= 50,000/uL
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Number of Participants With a Median Platelet Count >= 50,000/uL
|
30 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Participants who completed study. Statistical tests were not completed because a) Difficulty in obtaining accurate information on the reasons for platelet transfusion in the historical cohort and b) Several participants had platelet counts higher than threshold for starting transfusion, making comparisons not meaningful
Defined as the average number of days from the first day of eltrombopag until the first of five consecutive days with platelet counts \>= 50,000 /µL without a platelet transfusion. The time will be summarized using the Kaplan-Meier method and will use the logrank test and proportional hazards models.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days
|
7 days
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study. Statistical tests were not completed because a) Difficulty in obtaining accurate information on the reasons for platelet transfusion in the historical cohort and b) Several participants had platelet counts higher than threshold for starting transfusion, making comparisons not meaningful
Defined as the median number of days from the first day of eltrombopag until the patient stopped treatment. The time will be summarized using the Kaplan-Meier method and will use the log-rank test and proportional hazards models.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Median Days of Platelet Transfusions
|
10 days
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study
The number of bleeding events experienced by patients during treatment including hematuria, gastrointestinal bleed (with or without requiring intervention, retroperitoneal bleeding, intra-cranial bleed, epistaxis not controlled by conservative measures and muscle or soft tissue hematomas.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Rates of Clinically Significant Bleeding Events
|
0 events
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
The average number of days patients take to reach a neutrophil count \>500/ul as summarized using the Kaplan-Meier method and modeled using logrank test and proportional hazards.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
The median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level \<8g/dL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study
The percent of participants with a sustained improvement of platelet counts (independent of platelet transfusions) to ≥ 50,000 /µL lasting for at least 2 weeks.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Complete Response Rate
|
90 Percent of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study
The median number of days participants take to achieve a complete response as defined as a sustained improvement of platelet counts (independent of platelet transfusions) to ≥ 50,000 /µL lasting for at least 2 weeks.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Median Days to Attain Complete Response
|
30 days
Interval 25.0 to 34.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study
The number of participants with a sustained improvement of platelet counts (independent of platelet transfusions) seen by at least a doubling of platelet count from the pretreatment thrombocytopenic level (defined as \< 10000 /µL, ) or an absolute increase in platelet counts to between 30000 /µL and 50000 /µL, whichever is higher but not achieving complete response. Or if there is a need to restart eltrombopag due to drop in platelet count to below 50000 /µL following interruption of eltrombopag therapy after achieving platelet counts of \> 100000 /µL on the drug.
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Partial Complete Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
The average number of days from the the beginning of treatment to the onset of post-remission therapy as summarized using the Kaplan-Meier method and calculated using the logrank test and proportional hazards models.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who completed study
The number of participants with presence of morphologic evidence of disease
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Rate of Refractory or Persistent Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: at 28 days, at 6 months and up to 5 yearsPopulation: Participants who went on study
OS is defined from the day of study registration until the last follow-up or death
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Overall Survival (OS) - Percent of Participants Alive at Follow-up
28 days from start of treatment
|
100 percent of participants
|
|
Overall Survival (OS) - Percent of Participants Alive at Follow-up
6 months from start of treatment
|
74.2 percent of participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of eltrombopag olaminePopulation: Participants enrolled in study
Incidence of grade 3/4 adverse events (AE), determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. For full list, see AE/serious adverse event (SAE) section
Outcome measures
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 Participants
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
febrile neutropenia
|
1 Participants
|
|
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
thromboembolic event
|
1 Participants
|
|
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
rash
|
1 Participants
|
|
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
generalized myalgias
|
1 Participants
|
|
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
hypokalemia & hypocalhypokalemia & hypocalcemia
|
1 Participants
|
SECONDARY outcome
Timeframe: At 5 year follow-upCalculated from the date of complete remission until relapse, the date of last follow-up, or other protocol-defined event
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (Eltrombopag Olamine)
Serious events: 14 serious events
Other events: 25 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 participants at risk
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Cardiac disorders
Cardiac arrest
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Investigations
Alkaline phosphatase increased
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Investigations
Cardiac troponin T increased
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Acute kidney injury
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hematuria
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
19.4%
6/31 • Number of events 6 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
Other adverse events
| Measure |
Supportive Care (Eltrombopag Olamine)
n=31 participants at risk
Patients receive eltrombopag olamine PO QD until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
eltrombopag olamine: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.7%
12/31 • Number of events 14 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.0%
9/31 • Number of events 11 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Ear and labyrinth disorders
Ear pain
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
25.8%
8/31 • Number of events 8 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Ileus
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Nausea
|
19.4%
6/31 • Number of events 7 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Number of events 4 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Chills
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Edema limbs
|
29.0%
9/31 • Number of events 11 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Fatigue
|
9.7%
3/31 • Number of events 4 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Fever
|
16.1%
5/31 • Number of events 5 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Infections and infestations
Blood infections
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
6/31 • Number of events 8 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.4%
6/31 • Number of events 6 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.8%
8/31 • Number of events 9 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.9%
4/31 • Number of events 4 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.9%
4/31 • Number of events 5 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Number of events 7 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Psychiatric disorders
Confusion
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
5/31 • Number of events 5 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Number of events 2 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.4%
6/31 • Number of events 7 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • Number of events 3 • Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
|
Additional Information
Dr. Sudipto Mukherjee
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place