Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF (NCT NCT02846324)
NCT ID: NCT02846324
Last Updated: 2020-10-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Days 1 to 58
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
GBT440 600 mg Dose
Parts A and B
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900 mg Dose
Part A
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500 mg Dose
Part B
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
Placebo
Parts A and B
Placebo: Placebo capsules
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
14
|
10
|
|
Overall Study
Completed Study Treatment
|
7
|
5
|
11
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
GBT440 600 mg Dose
Parts A and B
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900 mg Dose
Part A
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500 mg Dose
Part B
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
Placebo
Parts A and B
Placebo: Placebo capsules
|
|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 Participants
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900 mg Dose
n=6 Participants
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500 mg Dose
n=14 Participants
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
n=5 Participants
|
72.0 years
n=7 Participants
|
64.5 years
n=5 Participants
|
69.5 years
n=4 Participants
|
71.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
00 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 58Population: Participant had at least one dose of study drug
Outcome measures
| Measure |
Placebo
n=10 Participants
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 Participants
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900mg Dose
n=6 Participants
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500mg Dose
n=14 Participants
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
|
8 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose onlyPopulation: Complete PK data was not analyzable for any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose onlyPopulation: Per protocol, analysis was to be conducted on complete PK analysis population; insufficient number of samples collected for pre-specified analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose onlyPopulation: Complete PK data were not analyzable for any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 28Data reported is change from baseline in Oxygen Saturation at rest
Outcome measures
| Measure |
Placebo
n=10 Participants
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 Participants
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900mg Dose
n=6 Participants
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500mg Dose
n=12 Participants
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
|---|---|---|---|---|
|
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest
|
-1.1 percent oxygen (%)
Standard Error 0.59
|
0.3 percent oxygen (%)
Standard Error 0.77
|
0.4 percent oxygen (%)
Standard Error 0.76
|
0.9 percent oxygen (%)
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: 6MWT
Change from Baseline to Day 28 after 6MWT
Outcome measures
| Measure |
Placebo
n=10 Participants
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 Participants
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900mg Dose
n=6 Participants
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500mg Dose
n=12 Participants
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
|---|---|---|---|---|
|
Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise
|
-1.7 percent oxygen (%)
Standard Error 1.64
|
2.9 percent oxygen (%)
Standard Error 2.11
|
3.5 percent oxygen (%)
Standard Error 2.16
|
3.5 percent oxygen (%)
Standard Error 1.56
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GBT440 600 mg Dose
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
GBT440 900 mg Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GBT440 1500 mg Dose
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 participants at risk
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900 mg Dose
n=6 participants at risk
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500 mg Dose
n=14 participants at risk
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Number of events 1 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukemia
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Number of events 1 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Number of events 1 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Cardiac disorders
Arterial Fibrillation
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Number of events 1 • Screening to Day 58
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Number of events 1 • Screening to Day 58
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Parts A and B
Placebo: Placebo capsules
|
GBT440 600 mg Dose
n=9 participants at risk
Parts A and B Dose 1
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 900 mg Dose
n=6 participants at risk
Part A Dose 2
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
GBT440 1500 mg Dose
n=14 participants at risk
Part B Dose 2; Overall Dose 3
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Nervous system disorders
headache
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
Nervous system disorders
dizziness
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Psychiatric disorders
anxiety
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Psychiatric disorders
insomnia
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Renal and urinary disorders
bilirubinuria
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Renal and urinary disorders
proteinuria
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Renal and urinary disorders
acute kidney injury
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Renal and urinary disorders
haematuria
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
idiopathic pulmonary fibrosis
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
rales
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
rash
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
rash generalised
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Skin and subcutaneous tissue disorders
rash pruritic
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.0%
2/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
Cardiac disorders
bradycardia
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Cardiac disorders
sinus bradycardia
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Cardiac disorders
ventricular extrasystoles
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/10 • Screening to Day 58
|
33.3%
3/9 • Screening to Day 58
|
33.3%
2/6 • Screening to Day 58
|
35.7%
5/14 • Screening to Day 58
|
|
Gastrointestinal disorders
nausea
|
20.0%
2/10 • Screening to Day 58
|
33.3%
3/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
28.6%
4/14 • Screening to Day 58
|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
flatulent
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
Gastrointestinal disorders
vomiting
|
10.0%
1/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Gastrointestinal disorders
dental carries
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
General disorders
fatigue
|
10.0%
1/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
General disorders
pyrexia
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
14.3%
2/14 • Screening to Day 58
|
|
General disorders
chills
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
General disorders
malaise
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
General disorders
oedema peripheral
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
General disorders
oedema
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Immune system disorders
drug hypersensitivity
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Immune system disorders
immunosuppression
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Infections and infestations
sinusitis
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Infections and infestations
viral infection
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Infections and infestations
viral upper respiratory tract infection
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Injury, poisoning and procedural complications
incision site pain
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Investigations
alanine immunotransferase increase
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Investigations
aspartate immunotransferase increase
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Investigations
eosinophil count increase
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Investigations
gamma/glutamyltransferase increase
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Investigations
lymph node palpable
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Investigations
oxygen saturation decrease
|
10.0%
1/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Investigations
platelet count increase
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
16.7%
1/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Investigations
urine leukocyte esterase
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
|
Investigations
weight decreased
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/10 • Screening to Day 58
|
0.00%
0/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
7.1%
1/14 • Screening to Day 58
|
|
Metabolism and nutrition disorders
fluid overload
|
0.00%
0/10 • Screening to Day 58
|
11.1%
1/9 • Screening to Day 58
|
0.00%
0/6 • Screening to Day 58
|
0.00%
0/14 • Screening to Day 58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place