Study: NCT01242371

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Schizophrenia exacerbation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dermatological condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was assessed separately and is counted as a separate adverse event from other gastrointestinal problems, which were solicited non-specifically.
Frequency: 9 affected / 33 at risk

Adverse event: Gastrointestonal symptoms (excluding diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-specific new onset gastrointestinal symptoms including constipation, heartburn, nausea, stomach cramps, and/or flatulence. Diarrhea was assessed separately and is counted as a separate adverse event.
Frequency: 5 affected / 33 at risk

Adverse event: Genitourinary condition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Musculoskelatol condition
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Psychiatric condition
Serious: no
Organ System: Psychiatric disorders
Notes: Psychiatric disease under study
Frequency: 4 affected / 33 at risk

Adverse event: Upper respiratory illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 33 at risk

Adverse event: Schizophrenia exacerbation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dermatological condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea was assessed separately and is counted as a separate adverse event from other gastrointestinal problems, which were solicited non-specifically.
Frequency: 6 affected / 32 at risk

Adverse event: Gastrointestonal symptoms (excluding diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-specific new onset gastrointestinal symptoms including constipation, heartburn, nausea, stomach cramps, and/or flatulence. Diarrhea was assessed separately and is counted as a separate adverse event.
Frequency: 7 affected / 32 at risk

Adverse event: Genitourinary condition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Musculoskelatol condition
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Psychiatric condition
Serious: no
Organ System: Psychiatric disorders
Notes: Psychiatric disease under study
Frequency: 2 affected / 32 at risk

Adverse event: Upper respiratory illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 32 at risk