Study: NCT00071110

Adverse event: ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Question 2: ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY: the patient's experience of lassitude and lack of endurance. The assessment is based upon the patient's reported statements.
Frequency: 1 affected / 28 at risk

Adverse event: SLEEPINESS / SEDATION
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Question 3: SLEEPINESS / SEDATION: diminished ability to stay awake during the day. The assessment is based on clinical signs during the interview.
Frequency: 1 affected / 28 at risk

Adverse event: FAILING MEMORY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q4-FAILING MEMORY: impaired memory. Assessment should be independent of any concentration difficulties.
Frequency: 1 affected / 28 at risk

Adverse event: TENSION / INNER UNREST
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q6-TENSION / INNER UNREST: inability to relax, nervous restlessness. This item is to be assessed on the basis of the patient's experience and must be distinguished from motor akathesia (Q16).
Frequency: 1 affected / 28 at risk

Adverse event: INCREASED DURATION OF SLEEP:
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q7-INCREASED DURATION OF SLEEP: this should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient's usual pre-illness state.
Frequency: 3 affected / 28 at risk

Adverse event: REDUCED DURATION OF SLEEP:
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q8-REDUCED DURATION OF SLEEP: should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient's usual pre-illness state.
Frequency: 7 affected / 28 at risk

Adverse event: INCREASED DREAM ACTIVITY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q9-INCREASED DREAM ACTIVITY: should be assessed independently of dream content and based on the average of sleep over the preceding nights in relation to the usual pre-illness dream activity.
Frequency: 9 affected / 28 at risk

Adverse event: EMOTIONAL INDIFFERENCE
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q10-EMOTIONAL INDIFFERENCE: a diminution of the patient's empathy, leading to apathy.
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q19-HEADACHE: on the scoring sheet headache is classified as (a) tension headache, (b) migraine, or (c) other forms of headache
Frequency: 8 affected / 28 at risk

Adverse event: NAUSEA / VOMITING
Serious: no
Organ System: Gastrointestinal disorders
Notes: UKU Q23-NAUSEA / VOMITING: to be recorded on the basis of the last 3 days.
Frequency: 7 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: UKU Q24-DIARRHEA: increased frequency and or thinner consistency of feces.
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q28-ORTHOSTATIC DIZZINESS: feeling of weakness, everything going black, buzzing in the ears, increasing tendency to faint when changing from supine or sitting position to upright position.
Frequency: 3 affected / 28 at risk

Adverse event: PALPITATIONS / TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Notes: UKU Q29-PALPITATIONS / TACHYCARDIA: palpitation, feeling of rapid, strong and /or irregular heartbeats.
Frequency: 2 affected / 28 at risk

Adverse event: INCREASED TENDENCY TO SWEATING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q30-INCREASED TENDENCY TO SWEATING: localized to the whole body, not only palms and soles of the foot.
Frequency: 3 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q31-RASH: for scoring, the types of rashes are classified as (a) morbilliform, (b) petechial, (c) urticarial, (d) psoriataic, and (e) cannot be classified.
Frequency: 1 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q33-PHOTOSENSITIVITY: increased sensitivity to sunlight.
Frequency: 2 affected / 28 at risk

Adverse event: DIMINISHED SEXUAL DESIRE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 28 at risk

Adverse event: ORGASMIC DYSFUNCTION
Serious: no
Organ System: Reproductive system and breast disorders
Notes: UKU Q45-(Sexually active females and males) ORGASMIC DYSFUNCTION: difficulty in obtaining and experiencing satisfactory orgasm.
Frequency: 7 affected / 28 at risk

Adverse event: DRY VAGINA
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Q46-(Sexually active females only) DRY VAGINA: dryness of vagina with sexual stimulation.
Frequency: 1 affected / 28 at risk

Adverse event: CONCENTRATION DIFFICULTIES
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Question 1: CONCENTRATION DIFFICULTIES: difficulties in ability to concentrate, to collect one's thoughts, or to sustain one's attention.
Frequency: 3 affected / 29 at risk

Adverse event: ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Question 2: ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY: the patient's experience of lassitude and lack of endurance. The assessment is based upon the patient's reported statements.
Frequency: 2 affected / 29 at risk

Adverse event: SLEEPINESS / SEDATION
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Question 3: SLEEPINESS / SEDATION: diminished ability to stay awake during the day. The assessment is based on clinical signs during the interview.
Frequency: 1 affected / 29 at risk

Adverse event: FAILING MEMORY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q4-FAILING MEMORY: impaired memory. Assessment should be independent of any concentration difficulties.
Frequency: 1 affected / 29 at risk

Adverse event: TENSION / INNER UNREST
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q6-TENSION / INNER UNREST: inability to relax, nervous restlessness. This item is to be assessed on the basis of the patient's experience and must be distinguished from motor akathesia (Q16).
Frequency: 3 affected / 29 at risk

Adverse event: INCREASED DURATION OF SLEEP:
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q7-INCREASED DURATION OF SLEEP: this should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient's usual pre-illness state.
Frequency: 4 affected / 29 at risk

Adverse event: REDUCED DURATION OF SLEEP:
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q8-REDUCED DURATION OF SLEEP: should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient's usual pre-illness state.
Frequency: 7 affected / 29 at risk

Adverse event: INCREASED DREAM ACTIVITY
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q9-INCREASED DREAM ACTIVITY: should be assessed independently of dream content and based on the average of sleep over the preceding nights in relation to the usual pre-illness dream activity.
Frequency: 12 affected / 29 at risk

Adverse event: EMOTIONAL INDIFFERENCE
Serious: no
Organ System: Psychiatric disorders
Notes: Udvalg Fur Kliniske Undersogesler (UKU) Q10-EMOTIONAL INDIFFERENCE: a diminution of the patient's empathy, leading to apathy.
Frequency: 2 affected / 29 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q15-TREMOR: this item comprises all forms of tremor.
Frequency: 1 affected / 29 at risk

Adverse event: PARATHESIAS
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q18-PARATHESIAS: pricking, creeping, or burning sensations in the skin.
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q19-HEADACHE: on the scoring sheet headache is classified as (a) tension headache, (b) migraine, or (c) other forms of headache
Frequency: 4 affected / 29 at risk

Adverse event: ACCOMMODATION DISTURBANCES
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q20-ACCOMMODATION DISTURBANCES: difficulty in seeing clearly or distinctly at close quarters (with or without glasses), whereas the patient sees clearly at a long distance (w/glasses if necessary)
Frequency: 1 affected / 29 at risk

Adverse event: NAUSEA / VOMITING
Serious: no
Organ System: Gastrointestinal disorders
Notes: UKU Q23-NAUSEA / VOMITING: to be recorded on the basis of the last 3 days.
Frequency: 3 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: UKU Q24-DIARRHEA: increased frequency and or thinner consistency of feces.
Frequency: 1 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: UKU Q25-CONSTIPATION: reduced frequency of defection and/or thicker consistency of feces.
Frequency: 3 affected / 29 at risk

Adverse event: MICTURITION DISTURBANCES
Serious: no
Organ System: Renal and urinary disorders
Notes: UKU Q26-MICTURITION DISTURBANCES: feeling of difficulty in starting and or resistance to micturition, weaker stream and/or increased time of micturition. Should be assessed on the basis of the last 3 days.
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Notes: UKU Q28-ORTHOSTATIC DIZZINESS: feeling of weakness, everything going black, buzzing in the ears, increasing tendency to faint when changing from supine or sitting position to upright position.
Frequency: 3 affected / 29 at risk

Adverse event: PALPITATIONS / TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Notes: UKU Q29-PALPITATIONS / TACHYCARDIA: palpitation, feeling of rapid, strong and /or irregular heartbeats.
Frequency: 1 affected / 29 at risk

Adverse event: INCREASED TENDENCY TO SWEATING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q30-INCREASED TENDENCY TO SWEATING: localized to the whole body, not only palms and soles of the foot.
Frequency: 1 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q31-RASH: for scoring, the types of rashes are classified as (a) morbilliform, (b) petechial, (c) urticarial, (d) psoriataic, and (e) cannot be classified.
Frequency: 2 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: UKU Q33-PHOTOSENSITIVITY: increased sensitivity to sunlight.
Frequency: 2 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: UKU Q37-(Menstruating females only) MENORRHAGIA: hypermenorrhea, polymenorrhea, or metrorrhagia during the last 3 months (or since last assessment).
Frequency: 1 affected / 29 at risk

Adverse event: DIMINISHED SEXUAL DESIRE
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 29 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: UKU Q43-(Sexually active males only) ERECTILE DYSFUNCTION: difficulty in attainting or maintaining an erection.
Frequency: 1 affected / 29 at risk

Adverse event: EJACULATORY DYSFUNCTION
Serious: no
Organ System: Reproductive system and breast disorders
Notes: UKU Q44-(Sexually active males only) EJACULATORY DYSFUNCTION: dysfunction of the patient's ability to control ejaculation. Includes (a) premature or (b) delayed ejaculation.
Frequency: 1 affected / 29 at risk

Adverse event: ORGASMIC DYSFUNCTION
Serious: no
Organ System: Reproductive system and breast disorders
Notes: UKU Q45-(Sexually active females and males) ORGASMIC DYSFUNCTION: difficulty in obtaining and experiencing satisfactory orgasm.
Frequency: 4 affected / 29 at risk