Study: NCT01407094

Adverse event: ER Visit
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ER visit with diagnosis of acute cholecystitis
Frequency: 1 affected / 283 at risk

Adverse event: ER Visit
Serious: yes
Organ System: General disorders
Notes: ER visit with fever
Frequency: 1 affected / 283 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Emergent suicidality
Frequency: 1 affected / 283 at risk

Adverse event: ER Visit
Serious: yes
Organ System: General disorders
Notes: Chest pain with emergency hospitalization; diagnosis of non-cardiac chest pain
Frequency: 1 affected / 283 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Panic attack, arrested
Frequency: 1 affected / 283 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain with emergency hospitalization
Frequency: 1 affected / 283 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening depression, suicidal ideation to ER
Frequency: 1 affected / 283 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Exited study due to pregnancy on 9/16/12 and gave birth to microcephalic child on 5/7/13
Frequency: 1 affected / 283 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening depression, suicidal ideation; psych hospitalization
Frequency: 1 affected / 283 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 283 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 283 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 283 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 33 affected / 283 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 41 affected / 283 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 283 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 57 affected / 283 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 283 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Endocrine disorders
Notes: Type-I Diabetes with brittle blood sugar control; hospital admin w/ ketoacidosis
Frequency: 1 affected / 196 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Involuntary hospitalization for suicidality
Frequency: 1 affected / 196 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening depression, suicidal ideation
Frequency: 1 affected / 196 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Panic attack
Frequency: 1 affected / 196 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Became pregnant
Frequency: 2 affected / 196 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization for suicidality
Frequency: 1 affected / 196 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 196 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 196 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 196 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 8 affected / 196 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 46 affected / 196 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 196 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 196 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 196 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Seizure
Frequency: 1 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 9 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 53 at risk