Study: NCT00044083

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was present in two patients in both arms of the protocol.
Frequency: 8 affected / 131 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Nervous system disorders
Notes: Sleep problems was present in three patients in both arms of the protocol.
Frequency: 8 affected / 131 at risk

Adverse event: Appetite Problems
Serious: no
Organ System: General disorders
Notes: Appetite problem was present in two patients in both arms of the protocol.
Frequency: 6 affected / 131 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was present in one patient in both arms of the protocol.
Frequency: 5 affected / 131 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Stiffness present in four patients in both arms of the protocol.
Frequency: 2 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was present in two patients in both arms of the protocol.
Frequency: 16 affected / 131 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Nervous system disorders
Notes: Sleep problems was present in three patients in both arms of the protocol.
Frequency: 10 affected / 131 at risk

Adverse event: Appetite Problems
Serious: no
Organ System: General disorders
Notes: Appetite problem was present in two patients in both arms of the protocol.
Frequency: 8 affected / 131 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was present in one patient in both arms of the protocol.
Frequency: 9 affected / 131 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Stiffness present in four patients in both arms of the protocol.
Frequency: 6 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was present in two patients in both arms of the protocol.
Frequency: 8 affected / 59 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Nervous system disorders
Notes: Sleep problems was present in three patients in both arms of the protocol.
Frequency: 6 affected / 59 at risk

Adverse event: Appetite Problems
Serious: no
Organ System: General disorders
Notes: Appetite problem was present in two patients in both arms of the protocol.
Frequency: 6 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was present in one patient in both arms of the protocol.
Frequency: 4 affected / 59 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Stiffness present in four patients in both arms of the protocol.
Frequency: 6 affected / 59 at risk

Adverse event: Halluciantions
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination was present in nine patients in both arms of the protocol. On patient reported hallucinations only on the placebo arm of the protocol.
Frequency: 10 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was present in two patients in both arms of the protocol.
Frequency: 5 affected / 60 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Nervous system disorders
Notes: Sleep problems was present in three patients in both arms of the protocol.
Frequency: 17 affected / 60 at risk

Adverse event: Appetite Problems
Serious: no
Organ System: General disorders
Notes: Appetite problem was present in two patients in both arms of the protocol.
Frequency: 5 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was present in one patient in both arms of the protocol.
Frequency: 7 affected / 60 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Stiffness present in four patients in both arms of the protocol.
Frequency: 11 affected / 60 at risk

Adverse event: Halluciantions
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination was present in nine patients in both arms of the protocol. On patient reported hallucinations only on the placebo arm of the protocol.
Frequency: 9 affected / 60 at risk