Trial Outcomes & Findings for American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL (NCT NCT00752895)
NCT ID: NCT00752895
Last Updated: 2021-09-28
Results Overview
An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
293 participants
Primary outcome timeframe
3 months
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Arm I - Ginseng
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
146
|
|
Overall Study
COMPLETED
|
139
|
143
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Arm I - Ginseng
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
Baseline Characteristics
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Baseline characteristics by cohort
| Measure |
Arm I - Ginseng
n=147 Participants
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
n=146 Participants
Patients receive oral placebo twice daily.
Placebo: Given orally
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
135 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
76 Participants
n=39 Participants
|
82 Participants
n=41 Participants
|
158 Participants
n=35 Participants
|
|
Age, Continuous
|
65 years
n=39 Participants
|
66 years
n=41 Participants
|
65 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
125 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=39 Participants
|
86 Participants
n=41 Participants
|
168 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=39 Participants
|
144 Participants
n=41 Participants
|
291 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=39 Participants
|
141 Participants
n=41 Participants
|
286 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=39 Participants
|
146 participants
n=41 Participants
|
293 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.
An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
Outcome measures
| Measure |
Arm I - Ginseng
n=137 Participants
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
n=143 Participants
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
Acute Respiratory Infection (ARI) Days
|
8.30 days
Standard Deviation 16.87
|
6.78 days
Standard Deviation 13.27
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.
An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
Outcome measures
| Measure |
Arm I - Ginseng
n=137 Participants
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
n=143 Participants
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
Number of Antibiotic Use Days
|
1.12 days
Standard Deviation 3.42
|
1.55 days
Standard Deviation 6.46
|
Adverse Events
Arm I - Ginseng
Serious events: 11 serious events
Other events: 121 other events
Deaths: 0 deaths
Arm II - Placebo
Serious events: 16 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Ginseng
n=140 participants at risk
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
n=143 participants at risk
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
General disorders
Pain: Chest/thorax NOS
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
General disorders
Pain:Stomach
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Blood and lymphatic system disorders
Platelets (160-360)
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 3 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion (non-malignant)
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Nervous system disorders
Seizure
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus Bradycardia
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Syncope (fainting)
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Infections and infestations
Infection with normal ANC or grade 1/2 neutrophils: Lung (pneumonia)
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Infections and infestations
Infection with normal ANC or Grade 1/2 neutrophils: Spleen
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Infections and infestations
Infection with unknown ANC: upper airway NOS
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Infections and infestations
Infection with unknown ANC: Brain (encephalitis)
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.71%
1/140 • Number of events 3 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
2.1%
3/143 • Number of events 5 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
General disorders
Pain: Abdomen NOS
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
2.1%
3/143 • Number of events 4 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
General disorders
Pain: Back
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
General disorders
Pain: Chest Wall
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
1.4%
2/143 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Cardiac ischemia/fnfarction
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
1.4%
2/143 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Diarrhea
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Diarrhea - without colostomy
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Ear and labyrinth disorders
Dizziness
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
2/140 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
1.4%
2/143 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
1.4%
2/143 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Nervous system disorders
Headache
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Hemorrhage, GI: Peritoneal cavity
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Hypertension
|
0.71%
1/140 • Number of events 2 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Infections and infestations
Infection with Grade 3/4 ANC: Skin
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Renal and urinary disorders
Urinary Frequency / Urgency
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Renal and urinary disorders
Urinary Frequency / Urgency - Pllakiuria
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Ventricular Arrhythmia NOS
|
0.71%
1/140 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.00%
0/143 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
0.70%
1/143 • Number of events 1 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
Other adverse events
| Measure |
Arm I - Ginseng
n=140 participants at risk
Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally
|
Arm II - Placebo
n=143 participants at risk
Patients receive oral placebo twice daily.
Placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea - without colostomy
|
10.7%
15/140 • Number of events 22 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
13.3%
19/143 • Number of events 25 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Nervous system disorders
Dizziness
|
12.1%
17/140 • Number of events 27 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
12.6%
18/143 • Number of events 24 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.9%
32/140 • Number of events 56 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
30.8%
44/143 • Number of events 70 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Nervous system disorders
Headache
|
27.1%
38/140 • Number of events 58 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
27.3%
39/143 • Number of events 63 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Heartburn
|
19.3%
27/140 • Number of events 46 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
25.2%
36/143 • Number of events 57 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
General disorders
Hemorrhage, Nose - Epistaxis
|
2.1%
3/140 • Number of events 4 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
7.7%
11/143 • Number of events 15 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Cardiac disorders
Hypertension
|
15.0%
21/140 • Number of events 34 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
16.1%
23/143 • Number of events 37 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Psychiatric disorders
Insomnia
|
39.3%
55/140 • Number of events 85 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
25.2%
36/143 • Number of events 63 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
8/140 • Number of events 9 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
9.8%
14/143 • Number of events 18 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Nervous system disorders
Neurology - Other - Nervousness
|
12.9%
18/140 • Number of events 22 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
7.7%
11/143 • Number of events 15 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
40.7%
57/140 • Number of events 110 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
45.5%
65/143 • Number of events 123 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Skin and subcutaneous tissue disorders
Rash / Desquamation
|
4.3%
6/140 • Number of events 6 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
9.1%
13/143 • Number of events 20 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Renal and urinary disorders
Urinary Frequency / Urgency - Pllakiuria
|
28.6%
40/140 • Number of events 77 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
23.1%
33/143 • Number of events 54 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
4/140 • Number of events 4 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
5.6%
8/143 • Number of events 8 • 5 months
Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place