Trial Outcomes & Findings for Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency (NCT NCT00498628)

NCT ID: NCT00498628

Last Updated: 2019-03-19

Results Overview

A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

224 participants

Primary outcome timeframe

Weeks 3 - 11

Results posted on

2019-03-19

Participant Flow

Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between December 2007 and May 2009.

218 comprises the Modified Intent To Treat group (MITT)

Participant milestones

Participant milestones
Measure	Quetiapine Fumerate Plus Medical Management Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management Medical management plus placebo comparator
Overall Study STARTED	105	113
Overall Study COMPLETED	90	92
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator	Total n=218 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=99 Participants	113 Participants n=107 Participants	218 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	45.4 years STANDARD_DEVIATION 9.3 • n=99 Participants	45.5 years STANDARD_DEVIATION 9.8 • n=107 Participants	45.4 years STANDARD_DEVIATION 9.4 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	26 Participants n=107 Participants	43 Participants n=206 Participants
Sex: Female, Male Male	88 Participants n=99 Participants	87 Participants n=107 Participants	175 Participants n=206 Participants
Region of Enrollment United States	105 participants n=99 Participants	113 participants n=107 Participants	218 participants n=206 Participants

PRIMARY outcome

Timeframe: Weeks 3 - 11

Population: Intention to Treat

A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Percent Heavy Drinking Days	37.1 percentage of heavy drinking days Standard Error 3.5	37.9 percentage of heavy drinking days Standard Error 3.34

SECONDARY outcome

Timeframe: Weeks 3-11

Timeline Follow-back drinking data is used to calculate the % of days abstinent per week during Weeks 3-11

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Percent Days Abstinent	49.5 percentage of days abstinent Standard Error 3.71	47.1 percentage of days abstinent Standard Error 3.54

SECONDARY outcome

Timeframe: Study Weeks 3-11

Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Drinks Per Drinking Day	6.2 drinks per drinking day Standard Error .47	6.3 drinks per drinking day Standard Error .45

SECONDARY outcome

Timeframe: Study Weeks 3-11

Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per day

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Drinks Per Day	4.3 drinks per day Standard Error 0.43	4.4 drinks per day Standard Error 0.41

SECONDARY outcome

Timeframe: Study Weeks 3-11

Timeline Follow Back data used to calculate the % of very heavy drinking days per week. Heavy drinking is 10+ drinks per day for females and 12+ drinks per day for males

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Percent Very Heavy Drinking Day	16.5 percentage heavy drinking days Standard Error 2.56	18.8 percentage heavy drinking days Standard Error 2.44

SECONDARY outcome

Timeframe: Study Weeks 3-11

Timeline Follow Back data used to calculate the % of subjects that maintained abstinence weeks 3-11.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Percent Subjects Abstinent	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Study Weeks 3-11

Timeline Follow Back data used to calculate the % of subjects that didn't have a heavy drinking day during study weeks 3-11.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Percent Subjects With no Heavy Drinking Day	17 Participants	24 Participants

SECONDARY outcome

Timeframe: Weeks 6 & 12

Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. We used a modified version of the DrInC that just included the 45-items that summed the Interpersonal, Physical, Social, and Impulsivity items. This total score (min=0, max=135) was analyzed in this study with high scores indicative of more alcohol-related consequences (a poor outcome for a given study participant). The DrInC was assessed at study weeks 6 and 12. Analyses averaged across these weeks.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Drinking Consequences Score	18.5 score on a scale Standard Error 1.87	22.5 score on a scale Standard Error 1.78

SECONDARY outcome

Timeframe: Weeks 4, 6, 8, 10, and 12

The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). The summed total score of the 5 items was used in the analysis (min=0, max=30) with higher scores indicative of higher craving for alcohol (a poor outcome). Based on clinical study results, the PACS has been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse. The PACS was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Penn Alcohol Craving Score (PACS_	12.1 score on a scale Standard Error 0.63	12.8 score on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: Weeks 3-11

The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is the sum of the 10-item in a checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60. Higher scores are indicative of greater depressive symptoms (a poor outcome). The MADRS was assessed at weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Montgomery-Asberg Depression Rating Scale (MADRS)	2.8 score on a scale Standard Error 0.39	4.1 score on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Weeks 4, 6, 8, 10, and 12

The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) (Guy, 1976). A total score is derived from the summed items (min=0, max=56) with higher scores indicative of greater anxiety (a poor outcome). The HAM-A was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Hamilton Anxiety Scale (HAM-A)	2.4 score on a scale Standard Error 0.26	3.0 score on a scale Standard Error .24

SECONDARY outcome

Timeframe: Weeks 4, 8, 12

The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); \>6 indicative of "poor" sleep quality. The PSQI was assessed at study weeks 4,8, and 12. Analyses averaged across these weeks.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Pittsburgh Sleep Quality Score	4.1 score Standard Error 0.27	5.1 score Standard Error 0.26

SECONDARY outcome

Timeframe: Week 12

The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status.

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Quality of Life SF - 12 - Mental Aggregate Score	51.5 score on a scale Standard Error 1.12	50.7 score on a scale Standard Error 1.08

SECONDARY outcome

Timeframe: Week 12

Population: mITT

Outcome measures

Outcome measures
Measure	Quetiapine Fumerate Plus Medical Management n=105 Participants Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 Participants Medical management plus placebo comparator
Quality of Life SF-12 - Physical Aggregate Score	51.0 score on a scale Standard Error 0.82	50.6 score on a scale Standard Error 0.93

Adverse Events

Quetiapine Fumerate Plus Medical Management

Serious events: 6 serious events

Other events: 105 other events

Deaths: 0 deaths

Sugar Pill Plus Medical Management

Serious events: 5 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Quetiapine Fumerate Plus Medical Management n=105 participants at risk Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 participants at risk Medical management plus placebo comparator
Psychiatric disorders Alcohol Detoxification	2.9% 3/105 • Number of events 4 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	2.7% 3/113 • Number of events 3 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Injury, poisoning and procedural complications Automobile Accident	0.95% 1/105 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.00% 0/113 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Behavioral Disturbance while intoxicated	0.00% 0/105 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.88% 1/113 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Cardiac disorders Pre-ventricular contractions	0.00% 0/105 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.88% 1/113 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Blood and lymphatic system disorders Ruptured Spleen	0.95% 1/105 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.00% 0/113 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Suicidal Ideation	0.95% 1/105 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.00% 0/113 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"

Other adverse events

Additional Information

Dr. Raye Litten

NIAAA

Phone: 301-443-0636

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Quetiapine Fumerate Plus Medical Management n=105 participants at risk Quetiapine fumarate - target dose 400mg/day plus medical management	Sugar Pill Plus Medical Management n=113 participants at risk Medical management plus placebo comparator
Nervous system disorders Dizziness	14.3% 15/105 • Number of events 20 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	4.4% 5/113 • Number of events 6 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Dry Mouth	32.4% 34/105 • Number of events 36 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	8.8% 10/113 • Number of events 11 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Dyspepsia	13.3% 14/105 • Number of events 22 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	1.8% 2/113 • Number of events 2 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Metabolism and nutrition disorders Increased Appetite	11.4% 12/105 • Number of events 12 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	0.88% 1/113 • Number of events 1 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Nervous system disorders Sedation	15.2% 16/105 • Number of events 18 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	2.7% 3/113 • Number of events 3 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Nervous system disorders Somnelence	34.3% 36/105 • Number of events 42 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	8.8% 10/113 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Nervous system disorders Headache	34.3% 36/105 • Number of events 60 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	43.4% 49/113 • Number of events 83 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Nervous system disorders Tremor	15.2% 16/105 • Number of events 19 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	12.4% 14/113 • Number of events 18 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Anxiety	19.0% 20/105 • Number of events 26 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	22.1% 25/113 • Number of events 33 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Insomnia	13.3% 14/105 • Number of events 15 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	21.2% 24/113 • Number of events 26 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Depressed Mood	6.7% 7/105 • Number of events 8 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	8.8% 10/113 • Number of events 13 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Abnormal Dreams	9.5% 10/105 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	7.1% 8/113 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Psychiatric disorders Agitation	9.5% 10/105 • Number of events 11 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	5.3% 6/113 • Number of events 8 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Nausea	9.5% 10/105 • Number of events 11 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	17.7% 20/113 • Number of events 25 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Vomiting	14.3% 15/105 • Number of events 20 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	12.4% 14/113 • Number of events 15 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Constipation	7.6% 8/105 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	7.1% 8/113 • Number of events 11 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Gastrointestinal disorders Diarrhoea	5.7% 6/105 • Number of events 7 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	9.7% 11/113 • Number of events 12 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
General disorders Fatigue	21.0% 22/105 • Number of events 29 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	15.0% 17/113 • Number of events 18 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
General disorders Feeling Abnormal	9.5% 10/105 • Number of events 11 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	7.1% 8/113 • Number of events 8 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
General disorders Irritability	7.6% 8/105 • Number of events 8 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	6.2% 7/113 • Number of events 9 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
General disorders Pain	5.7% 6/105 • Number of events 6 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	8.0% 9/113 • Number of events 9 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Respiratory, thoracic and mediastinal disorders Nasal Congestion	10.5% 11/105 • Number of events 14 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	9.7% 11/113 • Number of events 13 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Respiratory, thoracic and mediastinal disorders Cough	7.6% 8/105 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	11.5% 13/113 • Number of events 14 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Respiratory, thoracic and mediastinal disorders Oropharynageal Pain	8.6% 9/105 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	5.3% 6/113 • Number of events 7 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Investigations Weight Increased	19.0% 20/105 • Number of events 21 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	10.6% 12/113 • Number of events 13 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Investigations Blood Glucose Increased	2.9% 3/105 • Number of events 3 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	7.1% 8/113 • Number of events 9 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Musculoskeletal and connective tissue disorders Back Pain	7.6% 8/105 • Number of events 10 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	13.3% 15/113 • Number of events 22 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 9/105 • Number of events 12 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	4.4% 5/113 • Number of events 6 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Musculoskeletal and connective tissue disorders Mylagia	5.7% 6/105 • Number of events 6 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	3.5% 4/113 • Number of events 4 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Infections and infestations Upper Respiratory Tract Infection	3.8% 4/105 • Number of events 4 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	10.6% 12/113 • Number of events 12 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 7/105 • Number of events 7 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"	6.2% 7/113 • Number of events 7 Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"