Study: NCT02900352

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Notes: 1 participant (ppt) experienced stroke during study. Medication was tapered, blind was broken, ppt was withdrawn from study.
Frequency: 1 affected / 77 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: 1 ppt contacted study team to report suicidal ideation and possible attempt, they were assessed at a hospital and discharged home, were tapered off study medication and follow-up engaged in outpatient clinic.
Frequency: 1 affected / 77 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 77 at risk

Adverse event: Extreme Tiredness
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 77 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 77 at risk

Adverse event: Feeling Drowsy
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 77 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 77 at risk

Adverse event: Swelling or Puffiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Nasal Congestion/Runny Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 77 at risk

Adverse event: Rash or Skin Problem
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 77 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 77 at risk

Adverse event: Decreased Sex Drive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 77 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 77 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 77 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 77 at risk

Adverse event: Feeling dizzy, faint, lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Back, Muscle, or Bone Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 77 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 77 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 77 at risk

Adverse event: Teary or Dry Eyes
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 77 at risk

Adverse event: Extreme Thirst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 77 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 77 at risk

Adverse event: Memory Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 77 at risk

Adverse event: Difficulty concentrating or paying attention
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 77 at risk

Adverse event: Numbness or Tingling around Mouth, Fingers, or Toes
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 77 at risk

Adverse event: Swelling of Feet or Ankles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Restlessness, Can't sit still
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 77 at risk

Adverse event: Anger or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 77 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 77 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 77 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 77 at risk

Adverse event: Unusual Sensations on Skin
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 77 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 77 at risk

Adverse event: Problems with Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 77 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 77 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 77 at risk

Adverse event: Feeling Dizzy, Faint, or Lightheaded
Serious: no
Organ System: General disorders
Frequency: 11 affected / 77 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Trouble Walking
Serious: no
Organ System: General disorders
Frequency: 6 affected / 77 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Confusion or Slowed Thinking
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 77 at risk

Adverse event: Trouble Breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Change in Ability to Taste Food
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 77 at risk

Adverse event: Tremors or Shakiness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Trouble with Gums
Serious: no
Organ System: General disorders
Frequency: 3 affected / 77 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Unusual Bruising or Bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Double Vision or Changes In Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 77 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 77 at risk

Adverse event: Alcohol Withdrawal
Serious: yes
Organ System: Psychiatric disorders
Notes: 1 ppt had voluntarily requested treatment for detoxification. Ppt was admitted to 5 day inpatient alcohol detox.
Frequency: 1 affected / 79 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 ppt died in MVA while travelling out of state. Not study related and was on placebo. This incident was reported to the UConn IRB and Dr. Arias
Frequency: 1 affected / 79 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Extreme Tiredness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 79 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 79 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 79 at risk

Adverse event: Feeling Drowsy
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 79 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 79 at risk

Adverse event: Swelling or Puffiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 79 at risk

Adverse event: Nasal Congestion/Runny Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 79 at risk

Adverse event: Rash or Skin Problem
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 79 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 79 at risk

Adverse event: Decreased Sex Drive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 79 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 79 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 79 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Feeling dizzy, faint, lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 79 at risk

Adverse event: Back, Muscle, or Bone Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 79 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 79 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 79 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 79 at risk

Adverse event: Teary or Dry Eyes
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 79 at risk

Adverse event: Extreme Thirst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 79 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 79 at risk

Adverse event: Memory Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 79 at risk

Adverse event: Difficulty concentrating or paying attention
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 79 at risk

Adverse event: Numbness or Tingling around Mouth, Fingers, or Toes
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 79 at risk

Adverse event: Swelling of Feet or Ankles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 79 at risk

Adverse event: Restlessness, Can't sit still
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 79 at risk

Adverse event: Anger or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 79 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 79 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 79 at risk

Adverse event: Unusual Sensations on Skin
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 79 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 79 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Problems with Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 79 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 79 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 79 at risk

Adverse event: Feeling Dizzy, Faint, or Lightheaded
Serious: no
Organ System: General disorders
Frequency: 15 affected / 79 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Trouble Walking
Serious: no
Organ System: General disorders
Frequency: 10 affected / 79 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 79 at risk

Adverse event: Confusion or Slowed Thinking
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 79 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Trouble Breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Change in Ability to Taste Food
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 79 at risk

Adverse event: Tremors or Shakiness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 79 at risk

Adverse event: Trouble with Gums
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 79 at risk

Adverse event: Unusual Bruising or Bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 79 at risk

Adverse event: Double Vision or Changes In Vision
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 79 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk