Study: NCT01453439

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Increase in BDD and depressive Symptoms
Serious: yes
Organ System: Psychiatric disorders
Notes: Increase in BDD and depressive symptoms and relationship stressors.
Frequency: 1 affected / 61 at risk

Adverse event: Self-harm
Serious: yes
Organ System: Psychiatric disorders
Notes: The participant cut himself/herself with a box cutter when distressed; was hospitalized.
Frequency: 1 affected / 61 at risk

Adverse event: Negative reaction to anesthesia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The participant was hospitalized after a negative reaction to anesthesia. Symptoms included nausea and vomiting. The participant had received anesthesia for a more invasive procedure to address complications from a preexisting cyst.
Frequency: 1 affected / 61 at risk

Adverse event: Pain felt in one arm for a couple of days
Serious: yes
Organ System: General disorders
Notes: The participant was admitted to an emergency room due to pain felt in one arm for a couple of days and was kept overnight for monitoring and released the next day with no official diagnosis given.
Frequency: 1 affected / 61 at risk

Adverse event: Cardiac surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac surgery and recovery.
Frequency: 1 affected / 61 at risk

Adverse event: Increased anxiety and/or depression
Serious: no
Organ System: Psychiatric disorders
Notes: Increased depression or anxiety since starting study; no suicidal ideation.
Frequency: 8 affected / 61 at risk

Adverse event: Increase in other psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Patients reported isolated occurrences of or temporary increases in other psychiatric symptoms, including obsessive thoughts, BDD symptoms, stress, fatigue, irritability, or binge drinking.
Frequency: 8 affected / 61 at risk

Adverse event: Suicidal ideation and/or self-harm
Serious: no
Organ System: Psychiatric disorders
Notes: Occurrences of suicidal ideation or incidents of self-harm (e.g., cutting)
Frequency: 4 affected / 61 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AE descriptions included car accidents with minor injuries, broken or fractured bones, concussions, back injuries, accidental cut, ankle sprains, abrasion, alcohol poisoning, shoulder injury, cracked/chipped teeth, food poisoning, heat exhaustion
Frequency: 9 affected / 61 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: AE descriptions included (flare up of) herniated disks, headaches, migraines, spine troubles, pinched nerve, and sharp pain in head.
Frequency: 4 affected / 61 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE descriptions included flu, concerns about possible lung cancer (not detected), bronchitis, sore throat, and head and chest congestion.
Frequency: 2 affected / 61 at risk

Adverse event: Social circumstances
Serious: no
Organ System: Social circumstances
Notes: AE descriptions included friend dying in car crash, family conflict, spouse laid off from work, death of a parent, and hospitalization of a close family member.
Frequency: 2 affected / 61 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Notes: AE descriptions included minor outpatient surgery to to remove a splinter, cataract surgery, colonoscopy \& ultrasound for removal of precancerous cells, scheduled surgeries, and a visit to a chiropractor.
Frequency: 2 affected / 61 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Notes: Participant was hospitalized for one night for Mononucleosis (Mono) and was sick for 4 days.
Frequency: 1 affected / 59 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Notes: Anaphylactic shock
Frequency: 1 affected / 59 at risk

Adverse event: Increased anxiety and/or depression
Serious: no
Organ System: Psychiatric disorders
Notes: Increased depression or anxiety since starting study; no suicidal ideation.
Frequency: 13 affected / 59 at risk

Adverse event: Increase in other psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Patients reported isolated occurrences of or temporary increases in other psychiatric symptoms, including obsessive thoughts, BDD symptoms, stress, fatigue, irritability, or binge drinking.
Frequency: 3 affected / 59 at risk

Adverse event: Suicidal ideation and/or self-harm
Serious: no
Organ System: Psychiatric disorders
Notes: Occurrences of suicidal ideation or incidents of self-harm (e.g., cutting)
Frequency: 1 affected / 59 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AE descriptions included car accidents with minor injuries, broken or fractured bones, concussions, back injuries, accidental cut, ankle sprains, abrasion, alcohol poisoning, shoulder injury, cracked/chipped teeth, food poisoning, heat exhaustion
Frequency: 5 affected / 59 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: AE descriptions included (flare up of) herniated disks, headaches, migraines, spine troubles, pinched nerve, and sharp pain in head.
Frequency: 3 affected / 59 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE descriptions included flu, concerns about possible lung cancer (not detected), bronchitis, sore throat, and head and chest congestion.
Frequency: 3 affected / 59 at risk

Adverse event: Social circumstances
Serious: no
Organ System: Social circumstances
Notes: AE descriptions included friend dying in car crash, family conflict, spouse laid off from work, death of a parent, and hospitalization of a close family member.
Frequency: 3 affected / 59 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Notes: AE descriptions included minor outpatient surgery to to remove a splinter, cataract surgery, colonoscopy \& ultrasound for removal of precancerous cells, scheduled surgeries, and a visit to a chiropractor.
Frequency: 4 affected / 59 at risk