Study: NCT01749215

Adverse event: Inpatient hospitalization for lower quadrant pain, cough and chills
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: It was found that participant had a fever, increased white blood cells, and his lungs were filled with liquid. Veteran was prescribed amoxicillin and clavulonic acid for 7 days to treat aspiration pneumonia.
Frequency: 1 affected / 72 at risk

Adverse event: Inpatient hospitalization for pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Numbness or tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 72 at risk

Adverse event: Change in sense of taste
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 72 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 72 at risk

Adverse event: Difficulty with concentration or attention
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 72 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 72 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 19 affected / 72 at risk

Adverse event: Slow thinking
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 72 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 72 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 72 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 72 at risk

Adverse event: Language problems (e.g., word searching)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 72 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 72 at risk

Adverse event: Suicidal thoughts or actions
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 72 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 72 at risk

Adverse event: Difficulty with memory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 72 at risk

Adverse event: Inpatient hospitalization of less than 24 hours with diagnosis of Type 2 MI
Serious: yes
Organ System: Cardiac disorders
Notes: This happened in the context of cocaine and methamphetamine use, with discharge within 24 hours.
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient medical hospitalization for alcohol withdrawal.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported increased suicidal ideation and was willing to voluntarily go to psych emergency services (PES) at the SFVAMC. PES staff conducted their own assessment and concluded inpatient psychiatric hospitalization would be beneficial.
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: The participant voluntarily presented at PES at SFVAMC looking for housing. During routine assessment, participant reported cocaine use, hopelessness and thoughts of self-harm without a specific plan. Determined that needed to be admitted to PICU.
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient medical hospitalization due to abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The participant was brought by ambulance to the emergency department because of abdominal pain and vomiting. Participant has history of multiple bowel obstructions.
Frequency: 1 affected / 79 at risk

Adverse event: Death of research participant
Serious: yes
Organ System: General disorders
Notes: Coroner's report on cause of death: cocaine toxicity
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient hospitalization due to congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Thought to be secondary to hypertension and chronic alcohol use.
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient hospitalization due to suicidal ideation and alcohol withdrawal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient hospitalization due to shortness of breath in the setting of abdominal distension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was experiencing increased shortness of breath in the setting of abdominal distension and 20 pound weight gain over 3 months. Discharge diagnosis was COPD and lactose intolerance.
Frequency: 1 affected / 79 at risk

Adverse event: Inpatient hospitalization for MRSA
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Numbness or tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 79 at risk

Adverse event: Change in sense of taste
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 79 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 79 at risk

Adverse event: Difficulty with concentration or attention
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 19 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 20 affected / 79 at risk

Adverse event: Slow thinking
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 79 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 79 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 79 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 79 at risk

Adverse event: Language problems (e.g., word searching)
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 79 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 79 at risk

Adverse event: Suicidal thoughts or actions
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 79 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 79 at risk

Adverse event: Difficulty with memory
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 79 at risk