Trial Outcomes & Findings for The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients (NCT NCT01238120)

Last Updated: 2021-05-05

Results Overview

Memory performances (percent correct across delays) as assessed by the objective CANTAB delayed matching to sample task Percentage correct range (0 to 100) Higher percentage is better

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2021-05-05

Participant Flow

110 subjects were consented. Of those 110 subjects, 97 were randomized, 13 excluded. Of the 13 excluded, 7 were by the subject's request, 5 had a medical problem which rendered them ineligible, and 1 was a screening failure. Of the 97 subjects randomized, 11 participants were excluded. Of the 11 excluded, 9 were by the subject's request and 2 were lost to follow up. 86 participants received the intervention and completed baseline assessments (Overall Study Table Below).

Participant milestones

Participant milestones
Measure	Placebo and Home-Based Exercise 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart
Overall Study STARTED	25	23	25	24
Overall Study Received Intervention and Completed Baseline Assessments	21	22	22	21
Overall Study COMPLETED	17	22	21	18
Overall Study NOT COMPLETED	8	1	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo and Home-Based Exercise 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart
Overall Study Withdrawal by Subject	4	1	2	5
Overall Study Lost to Follow-up	2	0	1	1
Overall Study Withdrawn due to Medical Problem	2	0	1	0

Baseline Characteristics

The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo and Home-Based Exercise n=25 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo n=23 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise n=25 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID n=24 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart	Total n=97 Participants Total of all reporting groups
Age, Continuous	54.19 years STANDARD_DEVIATION 10.52 • n=93 Participants	54.95 years STANDARD_DEVIATION 12.51 • n=4 Participants	54.86 years STANDARD_DEVIATION 11.86 • n=27 Participants	50.29 years STANDARD_DEVIATION 8.92 • n=483 Participants	53.60 years STANDARD_DEVIATION 11.04 • n=36 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	22 Participants n=4 Participants	22 Participants n=27 Participants	21 Participants n=483 Participants	87 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	10 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=93 Participants	23 Participants n=4 Participants	24 Participants n=27 Participants	23 Participants n=483 Participants	95 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	6 Participants n=36 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	22 Participants n=4 Participants	24 Participants n=27 Participants	23 Participants n=483 Participants	89 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Cancer Type Breast	19 Participants n=93 Participants	19 Participants n=4 Participants	17 Participants n=27 Participants	18 Participants n=483 Participants	73 Participants n=36 Participants
Cancer Type Gastrointestinal	4 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants	5 Participants n=483 Participants	20 Participants n=36 Participants
Cancer Type Other	2 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	4 Participants n=36 Participants
Education Level Highschool/GED or less	4 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	11 Participants n=36 Participants
Education Level 2 to 4 Year Degree	13 Participants n=93 Participants	10 Participants n=4 Participants	11 Participants n=27 Participants	15 Participants n=483 Participants	49 Participants n=36 Participants
Education Level Graduate Degree	3 Participants n=93 Participants	8 Participants n=4 Participants	9 Participants n=27 Participants	4 Participants n=483 Participants	24 Participants n=36 Participants
Education Level Unknown	5 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	13 Participants n=36 Participants
Cancer Stage Stage 1	2 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	13 Participants n=36 Participants
Cancer Stage Stage 2	11 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	9 Participants n=483 Participants	33 Participants n=36 Participants
Cancer Stage Stage 3	4 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants	5 Participants n=483 Participants	26 Participants n=36 Participants
Cancer Stage Stage 4	8 Participants n=93 Participants	6 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants	25 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Note: Whenever the 6-week number of subject is less than the baseline number of subject this is due to the data not being available. n=17 for Placebo and Home-Based Exercise (1-withdrawal by subject, 1-lost to followup, 2-withdrawal due to medical reason); n=22 for Placebo Only; n=21 for Ibuprofen and Home-Based Exercise (1-withdrawal due to medical reason ); n=18 for Ibuprofen Only (2-withdrawal due to subject, 1=lost to followup)

Memory performances (percent correct across delays) as assessed by the objective CANTAB delayed matching to sample task Percentage correct range (0 to 100) Higher percentage is better

Outcome measures

Outcome measures
Measure	Placebo and Home-Based Exercise n=21 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo n=22 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise n=22 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID n=21 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm Basline	75.2 % correct Standard Deviation 19.9	82.7 % correct Standard Deviation 17.8	83.6 % correct Standard Deviation 19.2	74.3 % correct Standard Deviation 20.1
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm 6 Weeks	89.4 % correct Standard Deviation 10.3	90.0 % correct Standard Deviation 10.2	87.6 % correct Standard Deviation 16.1	90.0 % correct Standard Deviation 15.7

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Note: Whenever the 6-week number of subjects or baseline number of subjects is less than the number reported per arm this is due to the data not being available. n=17 for Placebo and Home-Based Exercise (1-withdrawal by subject, 1-lost to followup, 2-withdrawal due to medical reason); n=22 for Placebo Only; n=20 for Ibuprofen and Home-Based Exercise (1-withdrawal due to medical reason, 1-unknown ); n=18 for Ibuprofen Only (2-withdrawal due to subject, 1=lost to followup)

Cognitive functioning score as assessed subjectively by a psychometrically validated instrument (FACT-COG) - Perceived Cognitive Impairment (PCI) (min=0, max=116) Higher Score is better

Outcome measures

Outcome measures
Measure	Placebo and Home-Based Exercise n=21 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo n=22 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise n=22 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID n=21 Participants 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm Baseline	74.7 score on a scale Standard Deviation 22.0	72.7 score on a scale Standard Deviation 18.1	85.9 score on a scale Standard Deviation 17.1	76.2 score on a scale Standard Deviation 18.9
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm 6 Weeks	80.5 score on a scale Standard Deviation 19.7	76.5 score on a scale Standard Deviation 20.2	88.0 score on a scale Standard Deviation 21.0	78.9 score on a scale Standard Deviation 21.8

Adverse Events

Placebo and Home-Based Exercise

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ibuprofen 200mg BID, Home-Based Exercise

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ibuprofen 200 mg BID

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo and Home-Based Exercise n=25 participants at risk 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period Placebo: 200mg BID and 8 hours apart	Placebo n=23 participants at risk 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Ibuprofen 200mg BID, Home-Based Exercise n=25 participants at risk 200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period	Ibuprofen 200 mg BID n=24 participants at risk 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart
Gastrointestinal disorders Gastrointestinal disorders - Melena	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/24 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
General disorders Abdominal Pain	4.0% 1/25 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/24 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
Psychiatric disorders Suicidal ideation	4.0% 1/25 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/24 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
Eye disorders Otitis Media	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/24 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
General disorders Fever	4.0% 1/25 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/24 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
Renal and urinary disorders Infection - Urinary Tract	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/23 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	0.00% 0/25 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.	4.2% 1/24 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.

Other adverse events

Additional Information

Michelle C. Janelsins, PhD, MPH

University of Rochester Medical Center

Phone: (585) 276-4656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place