Trial Outcomes & Findings for Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (NCT NCT03572049)
NCT ID: NCT03572049
Last Updated: 2023-07-07
Results Overview
Percentage of participants to achieve therapeutic itraconazole and hydroxyitraconazole levels by evaluating Inter-patient variability as calculated by co-efficient of variation on plasma specimens collected on Day 14
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
88 participants
Primary outcome timeframe
Day 14
Results posted on
2023-07-07
Participant Flow
Participant milestones
| Measure |
SUBA Itraconazole
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
46
|
|
Overall Study
COMPLETED
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
Baseline characteristics by cohort
| Measure |
SUBA Itraconazole
n=42 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
48 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 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
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Percentage of participants to achieve therapeutic itraconazole and hydroxyitraconazole levels by evaluating Inter-patient variability as calculated by co-efficient of variation on plasma specimens collected on Day 14
Outcome measures
| Measure |
SUBA Itraconazole
n=42 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14
|
60.5 percentage of participants
|
71.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 42Comparison of the number of treatment related adverse events in each arm occurring Days 1-42.
Outcome measures
| Measure |
SUBA Itraconazole
n=42 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Frequency of Treatment Related Adverse Events Days 1-42
|
15 adverse events
|
27 adverse events
|
SECONDARY outcome
Timeframe: Day 42Percentage of patients with therapeutic itraconazole and hydroxyitraconazole levels as measured in plasma trough levels Day 42
Outcome measures
| Measure |
SUBA Itraconazole
n=42 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42
|
69.3 percentage of participants
|
58.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42We will measure specific signs and symptoms related to endemic fungal infection, comparing baseline findings to Day 42 findings using physical examination and patient history.
Outcome measures
| Measure |
SUBA Itraconazole
n=37 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=40 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42
|
29 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 180The number of days of Hospitalization occurring between Day 1-180
Outcome measures
| Measure |
SUBA Itraconazole
n=42 Participants
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 Participants
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
The Number of Days of Hospitalization at Day 180
|
5 Days
Interval 0.0 to 50.0
|
7 Days
Interval 0.0 to 50.0
|
Adverse Events
SUBA Itraconazole
Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths
Conventional Itraconazole
Serious events: 12 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SUBA Itraconazole
n=42 participants at risk
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 participants at risk
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
Infections and infestations
UTI Sepsis
|
2.4%
1/42 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
2.4%
1/42 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Metabolism and nutrition disorders
Hypomolar Nonketotic Hyperglycemia
|
2.4%
1/42 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Vascular disorders
Edema, lower extremities
|
2.4%
1/42 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Hypertrophic Obstructive Cardiomyopathy
|
2.4%
1/42 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Pregnancy, puerperium and perinatal conditions
Unintended Pregnancy
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in foot
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dypnea
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Hepatobiliary disorders
Liver Toxicity
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Hepatobiliary disorders
Ascites, worsening
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Fever
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Motor Vehicle Accident
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Pain
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Gastro-intestinal hemorrhage with hematemesis
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
4.3%
2/46 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Nausea, worsening
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Abdominal Cramping
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Diarrhea, worsening
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Cardiac Catheterization
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
2.2%
1/46 • Number of events 1 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
Other adverse events
| Measure |
SUBA Itraconazole
n=42 participants at risk
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
|
Conventional Itraconazole
n=46 participants at risk
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
|
|---|---|---|
|
General disorders
Rash
|
7.1%
3/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
8.7%
4/46 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Pruritus
|
7.1%
3/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Weight Gain
|
4.8%
2/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Weakness
|
9.5%
4/42 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Night sweats
|
4.8%
2/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Nausea
|
9.5%
4/42 • Number of events 5 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
15.2%
7/46 • Number of events 7 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Lightheadedness
|
4.8%
2/42 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
4.8%
2/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Nervous system disorders
Insomnia
|
7.1%
3/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Hypertension
|
9.5%
4/42 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
17.4%
8/46 • Number of events 8 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • Number of events 5 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
15.2%
7/46 • Number of events 7 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Fever
|
7.1%
3/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
8.7%
4/46 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Fatigue
|
9.5%
4/42 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Emesis
|
4.8%
2/42 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
15.2%
7/46 • Number of events 7 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Edema
|
28.6%
12/42 • Number of events 17 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
21.7%
10/46 • Number of events 12 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
2/42 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
21.7%
10/46 • Number of events 11 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Gastrointestinal disorders
Constipation
|
4.8%
2/42 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
8.7%
4/46 • Number of events 5 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Blurry Vision
|
4.8%
2/42 • Number of events 2 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Anorexia
|
7.1%
3/42 • Number of events 4 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
0.00%
0/46 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
General disorders
Weight loss
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
6.5%
3/46 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
6.5%
3/46 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Reproductive system and breast disorders
Dyspnea
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
8.7%
4/46 • Number of events 5 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
6.5%
3/46 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/42 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
6.5%
3/46 • Number of events 3 • Data regarding all adverse events were collected over 180 days (approximately 6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place