Study: NCT02960763

Adverse event: Non-psychiatric Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 211 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes instances of unrelated cancer and death to unrelated study cause
Frequency: 1 affected / 211 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Unable to be still, and having the constant urge to move
Frequency: 23 affected / 211 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 211 at risk

Adverse event: Reduced Salivation
Serious: no
Organ System: General disorders
Notes: dryness of mouth
Frequency: 15 affected / 211 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 211 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 211 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 211 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 32 affected / 211 at risk

Adverse event: Cold/Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 29 affected / 211 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 36 affected / 211 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 11 affected / 211 at risk

Adverse event: Increased Appetite Without Weight Gain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 211 at risk

Adverse event: Irritability or Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 211 at risk

Adverse event: Concenctration Difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 211 at risk

Adverse event: Asthenia/Lassitude/Increased Fatiguability
Serious: no
Organ System: General disorders
Frequency: 18 affected / 211 at risk

Adverse event: Sleepiness/Sedation
Serious: no
Organ System: General disorders
Frequency: 20 affected / 211 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: General disorders
Frequency: 30 affected / 211 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 14 affected / 211 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: frequent need to urinate/feeling of extreme thirstiness
Frequency: 5 affected / 211 at risk

Adverse event: Increased Tendency to Sweating
Serious: no
Organ System: General disorders
Frequency: 5 affected / 211 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 206 at risk

Adverse event: Non-psychiatric Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 206 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: required surgery/ER visit, but no known overnight hospitalization
Frequency: 1 affected / 206 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Unable to be still, and having the constant urge to move
Frequency: 2 affected / 206 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 206 at risk

Adverse event: Reduced Salivation
Serious: no
Organ System: General disorders
Notes: dryness of mouth
Frequency: 30 affected / 206 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 206 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 206 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 206 at risk

Adverse event: Cold/Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 18 affected / 206 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 41 affected / 206 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 16 affected / 206 at risk

Adverse event: Increased Appetite Without Weight Gain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 206 at risk

Adverse event: Irritability or Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 206 at risk

Adverse event: Concenctration Difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 206 at risk

Adverse event: Asthenia/Lassitude/Increased Fatiguability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 206 at risk

Adverse event: Sleepiness/Sedation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 206 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: General disorders
Frequency: 20 affected / 206 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 20 affected / 206 at risk

Adverse event: Increased Tendency to Sweating
Serious: no
Organ System: General disorders
Frequency: 8 affected / 206 at risk

Adverse event: Non-psychiatric Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 202 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: required surgery/ER visit, but no known overnight hospitalization
Frequency: 1 affected / 202 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes instances of unrelated cancer and death to unrelated study cause
Frequency: 1 affected / 202 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Unable to be still, and having the constant urge to move
Frequency: 5 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 202 at risk

Adverse event: Reduced Salivation
Serious: no
Organ System: General disorders
Notes: dryness of mouth
Frequency: 23 affected / 202 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 202 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 202 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 202 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 202 at risk

Adverse event: Cold/Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 23 affected / 202 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 40 affected / 202 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 15 affected / 202 at risk

Adverse event: Increased Appetite Without Weight Gain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 202 at risk

Adverse event: Irritability or Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 202 at risk

Adverse event: Concenctration Difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 202 at risk

Adverse event: Asthenia/Lassitude/Increased Fatiguability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 202 at risk

Adverse event: Sleepiness/Sedation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 202 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: General disorders
Frequency: 29 affected / 202 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 13 affected / 202 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: frequent need to urinate/feeling of extreme thirstiness
Frequency: 6 affected / 202 at risk

Adverse event: Increased Tendency to Sweating
Serious: no
Organ System: General disorders
Frequency: 5 affected / 202 at risk

Adverse event: Non-psychiatric Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 127 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Unable to be still, and having the constant urge to move
Frequency: 2 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 127 at risk

Adverse event: Reduced Salivation
Serious: no
Organ System: General disorders
Notes: dryness of mouth
Frequency: 13 affected / 127 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 127 at risk

Adverse event: Cold/Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 13 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 28 affected / 127 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 10 affected / 127 at risk

Adverse event: Increased Appetite Without Weight Gain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Irritability or Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 127 at risk

Adverse event: Concenctration Difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 127 at risk

Adverse event: Asthenia/Lassitude/Increased Fatiguability
Serious: no
Organ System: General disorders
Frequency: 18 affected / 127 at risk

Adverse event: Sleepiness/Sedation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 127 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: General disorders
Frequency: 8 affected / 127 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 34 affected / 127 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: frequent need to urinate/feeling of extreme thirstiness
Frequency: 11 affected / 127 at risk

Adverse event: Increased Tendency to Sweating
Serious: no
Organ System: General disorders
Frequency: 3 affected / 127 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 121 at risk

Adverse event: Non-psychiatric Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 121 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: required surgery/ER visit, but no known overnight hospitalization
Frequency: 1 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 121 at risk

Adverse event: Reduced Salivation
Serious: no
Organ System: General disorders
Notes: dryness of mouth
Frequency: 51 affected / 121 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 121 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 121 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 121 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 121 at risk

Adverse event: Cold/Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 13 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 121 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 5 affected / 121 at risk

Adverse event: Increased Appetite Without Weight Gain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 121 at risk

Adverse event: Irritability or Emotional Lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 121 at risk

Adverse event: Concenctration Difficulties
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 121 at risk

Adverse event: Asthenia/Lassitude/Increased Fatiguability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 121 at risk

Adverse event: Sleepiness/Sedation
Serious: no
Organ System: General disorders
Frequency: 12 affected / 121 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: General disorders
Frequency: 9 affected / 121 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 4 affected / 121 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: frequent need to urinate/feeling of extreme thirstiness
Frequency: 1 affected / 121 at risk

Adverse event: Increased Tendency to Sweating
Serious: no
Organ System: General disorders
Frequency: 6 affected / 121 at risk