Study: NCT01841359

Adverse event: Dehydration (r/t diarrhea)
Serious: yes
Organ System: General disorders
Notes: Not related to study drug / procedures (onset was prior to study drug initiation).

Pt was hospitalized 24 hrs. Resolved.
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhea (assoc. with dehydration requiring hospitalization)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Associated with dehydration. Not related to study drug / procedures (onset was prior to study drug initiation).

Pt was hospitalized 24 hrs. Resolved.
Frequency: 1 affected / 22 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Baseline (pre-study drug start) hypoglycemia (n=2) During study drug treatment hypoglycemia (n=2)
Frequency: 4 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Capillary glucose 450. Related to post-bariatric surgery status (rapid absorption / high peak of glucose levels).
Frequency: 1 affected / 22 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: Alcohol use acknowledged by participant, started on Campral since 10/18/14. Recovered / resolved.
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Possibly related to study drug. Pramlintide doses reduced (n=2). Nausea resolved or improved to baseline level of pre-existing nausea.
Frequency: 3 affected / 22 at risk

Adverse event: Altered taste (during treatment with study drug)
Serious: no
Organ System: General disorders
Notes: Related.
Frequency: 1 affected / 22 at risk

Adverse event: Ethanol abuse / intoxication
Serious: no
Organ System: Psychiatric disorders
Notes: Withdrawn from study, referred for support (AA, detox, alcohol detox specialist).
Frequency: 1 affected / 22 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Notes: Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment.
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhea (with urgency and incontinence)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Resolved.
Frequency: 1 affected / 22 at risk

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Notes: Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment.
Frequency: 1 affected / 22 at risk

Adverse event: Cold feeling behind eyes.
Serious: no
Organ System: General disorders
Notes: Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment.
Frequency: 1 affected / 22 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Notes: Resolved. Related to treatment. Withdrawn from study due to multiple symptoms related to treatment.
Frequency: 1 affected / 22 at risk

Adverse event: Increase in baseline anxiety.
Serious: no
Organ System: Psychiatric disorders
Notes: Withdrawn from study due to multiple symptoms related to treatment.
Frequency: 1 affected / 22 at risk

Adverse event: Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria)
Serious: no
Organ System: Renal and urinary disorders
Notes: No abnormal labs at V1/V2. U/A was negative for a urinary tract infection. Recovered without sequelae.
Frequency: 1 affected / 22 at risk

Adverse event: Cholecystitis (prior to treatment with study drug)
Serious: no
Organ System: Hepatobiliary disorders
Notes: Not related. Preexisting condition identified during screening process, patient not enrolled in study at that time. Not related recovered without sequelae.
Frequency: 1 affected / 22 at risk

Adverse event: Sinus infection (Visit 4, following treatment with study drug)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related. Recovered without sequelae.
Frequency: 1 affected / 22 at risk

Adverse event: Weight loss (during study drug treatment)
Serious: no
Organ System: General disorders
Notes: Possibly related. 6.6 lbs in 6 weeks. Related. Study drug dose decreased from 60 mcg to 30 mcg. Recovered without sequelae.
Frequency: 1 affected / 22 at risk