Study: NCT00118417

Adverse event: Patient admitted to the hospital after experiencing symptoms similar to panic attacks.
Serious: yes
Organ System: General disorders
Notes: This patient in Phase I of the study was admitted to the hospital after experiencing symptoms similar to, but more intense than panic attacks. The subject had not yet initiated study medication when the event occurred.
Frequency: 1 affected / 39 at risk

Adverse event: Patient was found to have blockage of one cardiac vessel
Serious: yes
Organ System: General disorders
Notes: Patient presented to the emergency room with sudden onset leg pain and was found to have blockage of one cardiac vessel. These symptoms were determined to be unrelated to the study medication (escitalopram); thus, her study treatment was not altered.
Frequency: 1 affected / 39 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 39 at risk

Adverse event: Nausea or Vomiting
Serious: no
Organ System: General disorders
Frequency: 15 affected / 39 at risk

Adverse event: Jitteriness or Restlesness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 39 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 24 at risk

Adverse event: Jitteriness or Restlesness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Patient admitted to inpatient rehabiliation center for alcohol abuse
Serious: yes
Organ System: General disorders
Notes: 1. A patient receiving Sertraline and Clonazepam was admitted to rehab center for alcohol abuse.
2. A patient who completed Phase III of the study, receiving Sertraline and Clonazepam, was admitted to rehab center for alcohol abuse.
Frequency: 2 affected / 19 at risk

Adverse event: Patient was in a motorcycle accident of unknown etiology
Serious: yes
Organ System: General disorders
Notes: This patient completed Phase III of the study (Sertraline and Clonazepam), and was involved in a motorcycle accident months after study completion. There is no evidence to indicate that the medication was related to the accident.
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 19 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk