Trial Outcomes & Findings for The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment (NCT NCT01318356)

Last Updated: 2021-06-23

Results Overview

The primary outcome measure is the fatigue severity measured by the subscale fatigue severity (8 items, 7-point Likert Scale) of the Checklist Individual Strength (CIS questionnaire) with a severity range from 8-56. High scores indicate a high level of fatigue. Patients with a cut-off score of ≥35 are classified as severely fatigued.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

156 participants

Primary outcome timeframe

24 weeks after start of treatment

Results posted on

2021-06-23

Participant Flow

156 patients signed informed consent and were randomized; of these, 155 started treatment, either doxycycline (n = 52), placebo (n = 52), or CBT (n = 51). One patient refused double-blind randomization after allocation to the medication group, and received no treatment.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Overall Study STARTED	51	52	52
Overall Study COMPLETED	43	49	50
Overall Study NOT COMPLETED	8	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy n=51 Participants Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 Participants Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 Participants Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)	Total n=155 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 13.7 • n=51 Participants	43.6 years STANDARD_DEVIATION 10.2 • n=52 Participants	44.6 years STANDARD_DEVIATION 12.3 • n=52 Participants	43.8 years STANDARD_DEVIATION 12.1 • n=155 Participants
Sex: Female, Male Female	25 Participants n=51 Participants	29 Participants n=52 Participants	20 Participants n=52 Participants	74 Participants n=155 Participants
Sex: Female, Male Male	26 Participants n=51 Participants	23 Participants n=52 Participants	32 Participants n=52 Participants	81 Participants n=155 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	51 participants n=51 Participants	52 participants n=52 Participants	52 participants n=52 Participants	155 participants n=155 Participants
Sickness Impact Profile 8 total score	1369.4 scores on a scale STANDARD_DEVIATION 646.7 • n=51 Participants	1304.9 scores on a scale STANDARD_DEVIATION 537.7 • n=52 Participants	1295.1 scores on a scale STANDARD_DEVIATION 593.7 • n=52 Participants	1322.8 scores on a scale STANDARD_DEVIATION 591.1 • n=155 Participants
Checklist Individual Strength, subscale fatigue	49.7 scores on a scale STANDARD_DEVIATION 4.7 • n=51 Participants	51.4 scores on a scale STANDARD_DEVIATION 4.7 • n=52 Participants	50.2 scores on a scale STANDARD_DEVIATION 4.8 • n=52 Participants	50.36 scores on a scale STANDARD_DEVIATION 4.9 • n=155 Participants
Symptom Checklist 90 total score	156.4 scores on a scale STANDARD_DEVIATION 35.0 • n=51 Participants	152.2 scores on a scale STANDARD_DEVIATION 31.4 • n=52 Participants	159.1 scores on a scale STANDARD_DEVIATION 41.0 • n=52 Participants	155.6 scores on a scale STANDARD_DEVIATION 36.0 • n=155 Participants
Duration of symptoms	40 months n=51 Participants	36 months n=52 Participants	37.50 months n=52 Participants	39 months n=155 Participants

PRIMARY outcome

Timeframe: 24 weeks after start of treatment

Population: Intention-to-treat analysis

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=50 Participants Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 Participants Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 Participants Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Checklist Individual Strength (CIS)	31.6 score on a scale Interval 28.0 to 35.1	40.8 score on a scale Interval 37.3 to 44.3	37.8 score on a scale Interval 34.3 to 41.2

SECONDARY outcome

Timeframe: 24 weeks after start of treatment

Population: Intention-to-treat analysis

Level of functional impairment measured with the Sickness Impact Profile (SIP). The SIP is an instrument that is used to gauge sickness-related dysfunction. The weighted total score on eight subscales of the SIP8 (SIP8 total score) will be used to assess functional disability in all domains of functioning (range 0-5799). A higher score indicates higher levels of functional impairment. A score of 450 or higher on the SIP is defined as being significant disabled because of fatigue.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=50 Participants Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 Participants Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 Participants Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Sickness Impact Profile (SIP) Total Score	786.8 score on a scale Interval 615.3 to 958.3	1101.5 score on a scale Interval 933.5 to 1269.6	963.8 score on a scale Interval 795.8 to 1131.9

SECONDARY outcome

Timeframe: 24 weeks after start of treatment

Population: Intention-to-treat analysis

The total score of the Symptom Checklist 90 (SCL90) measures the level of psychological distress. The SCL90 consists of 90 items scored on a 5-point scale. Scores range from 90 to 450. A low total score reflects high psychological well-being. The SCL-90 is a reliable and valid instrument.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy n=50 Participants Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 Participants Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 Participants Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Symptom Checklist 90 (SCL90)	127.1 score on a scale Interval 119.4 to 134.7	149.2 score on a scale Interval 141.6 to 156.7	142.6 score on a scale Interval 134.1 to 150.1

Adverse Events

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Doxycycline

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Behavioral Therapy n=50 participants at risk Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 participants at risk Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 participants at risk Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Renal and urinary disorders Urosepsis	0.00% 0/50 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	0.00% 0/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	1.9% 1/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Cardiac disorders Cardiological symptoms	0.00% 0/50 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	0.00% 0/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	1.9% 1/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).

Other adverse events

Other adverse events
Measure	Cognitive Behavioral Therapy n=50 participants at risk Cognitive behavioral therapy: CBT will consist of a protocolized intervention during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).	Doxycycline n=52 participants at risk Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.	Placebo n=52 participants at risk Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
Infections and infestations Infection	58.0% 29/50 • Number of events 54 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	42.3% 22/52 • Number of events 33 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	50.0% 26/52 • Number of events 46 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Gastrointestinal disorders Gastointestinal	10.0% 5/50 • Number of events 5 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	59.6% 31/52 • Number of events 51 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	51.9% 27/52 • Number of events 33 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Musculoskeletal and connective tissue disorders Muskuloskeletal	28.0% 14/50 • Number of events 18 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	42.3% 22/52 • Number of events 28 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	32.7% 17/52 • Number of events 22 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Skin and subcutaneous tissue disorders Skin	10.0% 5/50 • Number of events 5 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	38.5% 20/52 • Number of events 29 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	19.2% 10/52 • Number of events 12 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Nervous system disorders Neurological	12.0% 6/50 • Number of events 8 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	25.0% 13/52 • Number of events 13 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	19.2% 10/52 • Number of events 11 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Musculoskeletal and connective tissue disorders Bone and teeth	2.0% 1/50 • Number of events 1 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	5.8% 3/52 • Number of events 4 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	3.8% 2/52 • Number of events 2 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Immune system disorders Allergic reaction	0.00% 0/50 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	0.00% 0/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	0.00% 0/52 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
General disorders Other	36.0% 18/50 • Number of events 21 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	46.2% 24/52 • Number of events 34 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	25.0% 13/52 • Number of events 15 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).
Investigations Laboratorial	0.00% 0/50 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	26.9% 14/52 • Number of events 16 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).	13.5% 7/52 • Number of events 8 • Safety was assessed by monitoring adverse events (AEs) and concomitant drug use. For patients allocated to the medication condition, AEs were monitored at 4 weeks, 8 weeks, and 16 weeks after start of therapy, and at EOT (= up to approximately 26 weeks after start of therapy). Furthormore, if applicable, during the trial when reported by the patient. For patients allocated to CBT, AEs were monitored at 8 weeks after start of therapy, and at EOT (up to 26 weeks after start of therapy).

Additional Information

S.P. Keijmel, MD PhD

Radboud university medical center

Phone: 0031243611111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place