Trial Outcomes & Findings for Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy (NCT NCT04532372)
NCT ID: NCT04532372
Last Updated: 2024-07-03
Results Overview
MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
From the initial study treatment (Day 0) to Day 28.
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Phase I (Leflunomide, SOC)
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm I (Leflunomide, SOC)
Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
Baseline characteristics by cohort
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm I (Leflunomide, SOC)
Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
n=93 Participants
|
—
|
—
|
71.5 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
—
|
—
|
2 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
—
|
—
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
—
|
—
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
—
|
—
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
—
|
—
|
2 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From the initial study treatment (Day 0) to Day 28.Population: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I.
MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
Outcome measures
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) (Phase 1)
|
NA mg
Per study design, to determine MTD, it needs to have at least five accruals. So, MTD is unable to be determined for this study.
|
—
|
—
|
PRIMARY outcome
Timeframe: At day 28Population: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Defined as a \>= 2-point change in clinical status from day 1 on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Defined as time from start of treatment to \>= 2-point change in clinical status on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Outcome measures
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Time to Clinical Activity (Response)
|
9.5 days
Interval 5.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Defined as time from start of treatment to death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Time from start of treatment to peripheral capillary oxygen saturation (SpO2) \> 93% on room air.
Outcome measures
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Oxygen Saturation Improvement
|
6.5 days
Interval 1.0 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Indicate the participants who were hospitalized within first 90 days following start of treatment assessed.
Outcome measures
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Number of Participants Who Were Hospitalized
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
Indication the participants who were required mechanical ventilation at any time from start of treatment through 90 days post.
Outcome measures
| Measure |
Phase I (Leflunomide, SOC)
n=2 Participants
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
Phase II Arm II (Placebo, SOC)
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Best Practice: Receive standard of care drugs
Placebo Administration: Given PO
|
|---|---|---|---|
|
Number of Participants Who Were Mechanical Ventilation Required
|
0 Participants
|
—
|
—
|
Adverse Events
Phase I (Leflunomide, SOC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase I (Leflunomide, SOC)
n=2 participants at risk
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Best Practice: Receive standard of care drugs
Leflunomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
General disorders
FATIGUE
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
General disorders
FEVER
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
General disorders
GENERALIZED EDEMA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Infections and infestations
COVID-19
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
50.0%
1/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
50.0%
1/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
100.0%
2/2 • Number of events 3 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
50.0%
1/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
PLATELET COUNT DECREASED
|
100.0%
2/2 • Number of events 3 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
100.0%
2/2 • Number of events 3 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
50.0%
1/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Metabolism and nutrition disorders
OBESITY
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Nervous system disorders
ANOSMIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Nervous system disorders
DIZZINESS
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Nervous system disorders
DYSGEUSIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Nervous system disorders
HEADACHE
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Psychiatric disorders
INSOMNIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Renal and urinary disorders
NOCTURIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Vascular disorders
HYPERTENSION
|
100.0%
2/2 • Number of events 3 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
|
Vascular disorders
HYPOTENSION
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored and assessed from initial treatment to the end of the study, at D1, D2, D3, D4, D5, D6, D7, D8-14, D15-28, D42, D56, D70 and D90. Vital status was assessed from the initial treatment to the end of the study, up to 90 days after the end of the treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place