Trial Outcomes & Findings for Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community (NCT NCT00966446)

NCT ID: NCT00966446

Last Updated: 2019-07-05

Results Overview

Confirmed new MRSA infections

Recruitment status

COMPLETED

Study phase

Target enrollment

223 participants

Primary outcome timeframe

Within 6 months

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Unsupervised Decolonization Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.	Supervised Decolonization Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.	No Intervention Households do not undergo active MRSA decolonization protocol
Overall Study STARTED	76	74	73
Overall Study COMPLETED	48	49	52
Overall Study NOT COMPLETED	28	25	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unsupervised Decolonization n=76 Participants This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the "no intervention" group.	Supervised Decolonization n=74 Participants This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.	No Intervention n=73 Participants Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).	Total n=223 Participants Total of all reporting groups
Age, Categorical <=18 years	35 Participants n=5 Participants	37 Participants n=7 Participants	38 Participants n=5 Participants	110 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	106 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	43 Participants n=7 Participants	45 Participants n=5 Participants	128 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	95 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	67 Participants n=7 Participants	68 Participants n=5 Participants	203 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants	47 Participants n=7 Participants	47 Participants n=5 Participants	135 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment United States	76 participants n=5 Participants	74 participants n=7 Participants	73 participants n=5 Participants	223 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 6 months

Population: These study participants who self-reported re-infections of MRSA

Confirmed new MRSA infections

Outcome measures

Outcome measures
Measure	Unsupervised Decolonization n=48 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7	Supervised Decolonization n=49 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders	No Intervention n=52 Participants No decolonization agents
Recurrent Infection	1 participants	3 participants	1 participants

PRIMARY outcome

Timeframe: Within 2 months

Population: These subjects sent in two consecutive swab samples starting with their first follow-up time point.

Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis

Outcome measures

Outcome measures
Measure	Unsupervised Decolonization n=48 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7	Supervised Decolonization n=49 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders	No Intervention n=52 Participants No decolonization agents
First Two Consecutive Sampling Periods Completed	48 participants	49 participants	52 participants

SECONDARY outcome

Timeframe: Within 6 months

Population: Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization

Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.

Outcome measures

Outcome measures
Measure	Unsupervised Decolonization n=48 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7	Supervised Decolonization n=49 Participants Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders	No Intervention n=52 Participants No decolonization agents
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization	23 days Interval 17.0 to 29.0	23 days Interval 17.0 to 29.0	19 days Interval 15.0 to 33.0

Adverse Events

Unsupervised Decolonization

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Supervised Decolonization

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

No Intervention

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Unsupervised Decolonization n=76 participants at risk Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.	Supervised Decolonization n=74 participants at risk Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.	No Intervention n=73 participants at risk Households do not undergo active MRSA decolonization protocol
Cardiac disorders heart disease	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/73 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Metabolism and nutrition disorders Anorexia nervosa	2.6% 2/76 • Number of events 2 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Injury, poisoning and procedural complications homocide	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Metabolism and nutrition disorders inflammatory bowel	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Reproductive system and breast disorders cancer	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Cardiac disorders hypertension	2.6% 2/76 • Number of events 2 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Blood and lymphatic system disorders cancer	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Gastrointestinal disorders hemmorage	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/73 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders abscess	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/74 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.

Other adverse events

Additional Information

Ebbing Lautenbach, MD, MPH, MSCE

Perelman School of Medicine, University of Pennsylvania

Phone: 215-898-6977

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Unsupervised Decolonization n=76 participants at risk Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.	Supervised Decolonization n=74 participants at risk Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.	No Intervention n=73 participants at risk Households do not undergo active MRSA decolonization protocol
General disorders runny nose	5.3% 4/76 • Number of events 4 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/74 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Infections and infestations abscess	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders burning	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/74 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Injury, poisoning and procedural complications Broken bone	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders feel sick	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	5.4% 4/74 • Number of events 4 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders nasal congestion	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	8.1% 6/74 • Number of events 6 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders headache	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders sore throat	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	2.7% 2/74 • Number of events 2 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders common cold	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Infections and infestations fever	6.6% 5/76 • Number of events 5 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Infections and infestations flu	3.9% 3/76 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders itching	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/74 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders irritation	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	2.7% 2/74 • Number of events 2 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders rash	1.3% 1/76 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/74 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Skin and subcutaneous tissue disorders dry skin	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	4.1% 3/74 • Number of events 3 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
General disorders sneezing	0.00% 0/76 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	1.4% 1/74 • Number of events 1 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.	0.00% 0/73 • 1 week Serious adverse events include: * Death * Life threatening adverse experience * Inpatient hospitalization/prolongation of existing hospitalization * Persistent disability/incapacity * Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.