Study: NCT02500602

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Internal hemorrhoids
Frequency: 1 affected / 74 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pancreatitis
Frequency: 1 affected / 74 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Participant admitted to hospital for dehydration secondary to viral gastroenteritis
Frequency: 1 affected / 74 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Suicidal Ideation/Attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 74 at risk

Adverse event: Anger/Frustration
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Homicidal Ideation/Aggression
Serious: yes
Organ System: Psychiatric disorders
Notes: Placebo - participant reported feeling extreme anger related to housing. Reported 'intent to harm others' to police in order to be admitted to hospital.

Dox-Participant expressed homicidal ideation towards VA security guard and MD
Frequency: 1 affected / 74 at risk

Adverse event: Substance use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Diabetes Complications
Serious: yes
Organ System: Endocrine disorders
Notes: Dox - Diabetes mellitus with metabolic acidosis Placebo - insulin stopped working
Frequency: 1 affected / 74 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 74 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 74 at risk

Adverse event: Stomach Virus/Cramping/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 74 at risk

Adverse event: Cold/Sinus/Congestion
Serious: no
Organ System: General disorders
Frequency: 7 affected / 74 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 74 at risk

Adverse event: Generalized Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

Adverse event: Accident/Injury
Serious: no
Organ System: General disorders
Frequency: 8 affected / 74 at risk

Adverse event: Joint/Muscle Pain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 74 at risk

Adverse event: Drowsiness/Grogginess
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 74 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 74 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 74 at risk

Adverse event: Vivid Dreams/Nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 74 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Pt experienced chest pain and was sent to ER by PCP, admitted to hospital for 2 days. Event occurred prior to any medication administration.
Frequency: 1 affected / 70 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant fell while running, fractured left shoulder
Frequency: 1 affected / 70 at risk

Adverse event: Suicidal Ideation/Attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Homicidal Ideation/Aggression
Serious: yes
Organ System: Psychiatric disorders
Notes: Placebo - participant reported feeling extreme anger related to housing. Reported 'intent to harm others' to police in order to be admitted to hospital.

Dox-Participant expressed homicidal ideation towards VA security guard and MD
Frequency: 1 affected / 70 at risk

Adverse event: Substance use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 70 at risk

Adverse event: Panic Attack/Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Diabetes Complications
Serious: yes
Organ System: Endocrine disorders
Notes: Dox - Diabetes mellitus with metabolic acidosis Placebo - insulin stopped working
Frequency: 1 affected / 70 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 70 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Stomach Virus/Cramping/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Cold/Sinus/Congestion
Serious: no
Organ System: General disorders
Frequency: 14 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk

Adverse event: Generalized Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Accident/Injury
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Joint/Muscle Pain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 70 at risk

Adverse event: Drowsiness/Grogginess
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 70 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 70 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 70 at risk

Adverse event: Vivid Dreams/Nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 70 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 70 at risk