Study: NCT00548327

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Mild. Present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Mild. Present in both arms of the protocol in one healthy volunteer and one patient
Frequency: 1 affected / 5 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild in two patients,one of them on placebo and moderate in one HV
Frequency: 1 affected / 5 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients had the side effect during both arms of the protocol
Frequency: 2 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: One subject had the side effect in both arms of the protocol.
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Notes: Fatigue was present in 2 patients and 1 HV in both arms of the protocol.
Frequency: 2 affected / 5 at risk

Adverse event: Sexual dysfuntion
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Side effect was present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Urinary difficulties
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Side effect present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Side effect present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Side effect present in one patient in both arms of the protocol
Frequency: 1 affected / 5 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Mild. Present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Mild. Present in both arms of the protocol in one healthy volunteer and one patient
Frequency: 1 affected / 5 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild in two patients,one of them on placebo and moderate in one HV
Frequency: 1 affected / 5 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients had the side effect during both arms of the protocol
Frequency: 2 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: One subject had the side effect in both arms of the protocol.
Frequency: 2 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Notes: Fatigue was present in 2 patients and 1 HV in both arms of the protocol.
Frequency: 2 affected / 5 at risk

Adverse event: Sexual dysfuntion
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Side effect was present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Side effect present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Side effect present in both arms of the protocol in one patient
Frequency: 1 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Side effect present in one patient in both arms of the protocol
Frequency: 1 affected / 5 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Mild. Present in both arms of the protocol in one patient
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Mild. Present in both arms of the protocol in one healthy volunteer and one patient
Frequency: 1 affected / 6 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild in two patients,one of them on placebo and moderate in one HV
Frequency: 2 affected / 6 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients had the side effect during both arms of the protocol
Frequency: 4 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: One subject had the side effect in both arms of the protocol.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Notes: Fatigue was present in 2 patients and 1 HV in both arms of the protocol.
Frequency: 3 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: unusual thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Mild. Present in both arms of the protocol in one healthy volunteer and one patient
Frequency: 1 affected / 6 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients had the side effect during both arms of the protocol
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Notes: Fatigue was present in 2 patients and 1 HV in both arms of the protocol.
Frequency: 1 affected / 6 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk