Trial Outcomes & Findings for Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia (NCT NCT01969799)
NCT ID: NCT01969799
Last Updated: 2017-07-02
Results Overview
Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
10 day treatment period.
Results posted on
2017-07-02
Participant Flow
The trial was designed to have 150 patients, hoping to have at least 140 patients with proven gram negative pneumonia. The trial was terminated at 143 when that goal was achieved.
Participant milestones
| Measure |
Amikacin Fosfomycin Inhalation Solution
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
|
Overall Study
COMPLETED
|
54
|
58
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
Reasons for withdrawal
| Measure |
Amikacin Fosfomycin Inhalation Solution
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
16
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
Baseline characteristics by cohort
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=72 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 day treatment period.Population: MITT
Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .
|
-0.76 units on a scale
Standard Error 0.403
|
-0.88 units on a scale
Standard Error 0.391
|
SECONDARY outcome
Timeframe: Day 1 - Day 28Population: MITT
The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 \< 6). The tables reflect a winner of matched pairs, ties are not noted.
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Composite Endpoint of Mortality and Clinical Cure
Mortality first
|
10 participants
|
10 participants
|
|
Composite Endpoint of Mortality and Clinical Cure
Clinical Cure first
|
15 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Day 1- Day 28Population: MITT
The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Composite Endpoint of Mortality and Ventilator-free Days
Mortality first
|
10 participants
|
10 participants
|
|
Composite Endpoint of Mortality and Ventilator-free Days
Ventilator free days
|
13 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 28Population: MITT
Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28
|
9.8 Days ± SD
Standard Deviation 9.71
|
12.5 Days ± SD
Standard Deviation 9.72
|
SECONDARY outcome
Timeframe: Day 1 - Day 28Population: MITT
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Number of ICU Days From Day 1 Through Day 28
|
28.9 Days
Standard Deviation 12.44
|
26.2 Days
Standard Deviation 12.44
|
SECONDARY outcome
Timeframe: Day 14Population: patients with MDR bacteria at baseline BAL
Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=23 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=16 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 28Population: MITT
Mortality from Day 1 through Day 28, all causes, does not reflect just infection only
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Mortality From Day 1 Through Day 28
|
17 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Day 11 - Day 28Population: MITT
Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28
Outcome measures
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 Participants
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=71 Participants
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Clinical Relapse Rate
|
10 participants
|
14 participants
|
Adverse Events
Amikacin Fosfomycin Inhalation Solution
Serious events: 28 serious events
Other events: 54 other events
Deaths: 0 deaths
Aerosolized Placebo
Serious events: 27 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 participants at risk
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=72 participants at risk
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Infections and infestations
Septic shock
|
5.6%
4/71 • Number of events 4 • 28 days
|
8.3%
6/72 • Number of events 6 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.2%
3/71 • Number of events 3 • 28 days
|
2.8%
2/72 • Number of events 5 • 28 days
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
4.2%
3/71 • Number of events 3 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Sepsis
|
2.8%
2/71 • Number of events 2 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Infections and infestations
Pneumonia (new pathogen than baseline)
|
1.4%
1/71 • Number of events 1 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Cardiac disorders
Cardiac arrest
|
2.8%
2/71 • Number of events 2 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Vascular disorders
Shock haemorrhagic
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Lung abscess
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Meningitis
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Peritonitis
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Infections and infestations
Systemic candida
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/71 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Nervous system disorders
Brain oedema
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Nervous system disorders
Cerebral ischaemia
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
|
Nervous system disorders
Convulsion
|
1.4%
1/71 • Number of events 1 • 28 days
|
0.00%
0/72 • 28 days
|
Other adverse events
| Measure |
Amikacin Fosfomycin Inhalation Solution
n=71 participants at risk
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
|
Aerosolized Placebo
n=72 participants at risk
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyopokalaemia
|
8.5%
6/71 • Number of events 6 • 28 days
|
8.3%
6/72 • Number of events 8 • 28 days
|
|
Infections and infestations
Septic shock
|
5.6%
4/71 • Number of events 4 • 28 days
|
9.7%
7/72 • Number of events 7 • 28 days
|
|
Infections and infestations
Pneumonia
|
7.0%
5/71 • Number of events 5 • 28 days
|
6.9%
5/72 • Number of events 5 • 28 days
|
|
Infections and infestations
Sepsis
|
7.0%
5/71 • Number of events 5 • 28 days
|
5.6%
4/72 • Number of events 4 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
4/71 • Number of events 5 • 28 days
|
6.9%
5/72 • Number of events 6 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.0%
5/71 • Number of events 6 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.2%
3/71 • Number of events 3 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.8%
2/71 • Number of events 2 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.8%
2/71 • Number of events 4 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.8%
2/71 • Number of events 2 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/71 • Number of events 6 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
1.4%
1/71 • Number of events 1 • 28 days
|
2.8%
2/72 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
2/71 • Number of events 2 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/71 • Number of events 1 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/71 • Number of events 2 • 28 days
|
5.6%
4/72 • Number of events 5 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/71 • Number of events 1 • 28 days
|
6.9%
5/72 • Number of events 5 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/71 • Number of events 3 • 28 days
|
4.2%
3/72 • Number of events 3 • 28 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.8%
2/71 • Number of events 2 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • Number of events 2 • 28 days
|
1.4%
1/72 • Number of events 1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place