Study: NCT03255629

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pt was not randomized. hypokalemia discovered during screening visit; admitted to hospital. resolved without sequelae.

not related to study protocol or intervention.
Frequency: 1 affected / 18 at risk

Adverse event: Hyperkalemia at screening visit
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Discovered at screening visit. No treatment. Labs were repeated at Visit 2, potassium was within reference range.
Frequency: 1 affected / 18 at risk

Adverse event: MCH above normal limit of refrence range at screening visit.
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: No treatment. Complete blood count (CBC) repeated on 2/28/2018.Labs were acceptable to begin study visit.
Frequency: 1 affected / 18 at risk

Adverse event: WBC above normal limit of reference range at screening visit
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: No treatment. CBC repeated on 2/28/2018.Labs were acceptable to begin study visit.
Frequency: 1 affected / 18 at risk

Adverse event: Headache prior to start of MMTT
Serious: no
Organ System: General disorders
Notes: Not related to study drug or placebo as was present upon arrival.
Frequency: 2 affected / 18 at risk

Adverse event: Tiredness prior to start of MMTT
Serious: no
Organ System: General disorders
Notes: Not related to study drug or placebo as was present upon arrival to study visit.
Frequency: 1 affected / 18 at risk

Adverse event: Nausea after intake of mixed meal (prior to glucagon OR placebo)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to mixed meal tolerance test (MMTT). Resolved without sequelae.
Frequency: 12 affected / 18 at risk

Adverse event: Headache after intake of mixed meal (prior to glucagon OR placebo)
Serious: no
Organ System: General disorders
Notes: Related to MMTT. Resolved without sequelae.
Frequency: 7 affected / 18 at risk

Adverse event: Palpitations after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: Cardiac disorders
Notes: Related to MMTT. Resolved without sequelae.
Frequency: 6 affected / 18 at risk

Adverse event: Emesis after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse event (AE) linked to meal tolerance test, especially in patient population under study. Required ER evaluation in 1 participant due to repetitive vomiting. All resolved.
Frequency: 2 affected / 18 at risk

Adverse event: Feeling cold / chills after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: Related to MMTT, resolved.
Frequency: 3 affected / 18 at risk

Adverse event: Feeling hot / warm after intake of mixed meal (prior to study drug or placebo)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 6 affected / 18 at risk

Adverse event: Thirsty after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: Related to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Tiredness after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 11 affected / 18 at risk

Adverse event: Stomach ache / cramping after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 2 affected / 18 at risk

Adverse event: Bloated / uncomfortably full after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Blurry vision after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: Eye disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Tingling (paresthesia) in shoulders after intake of mixed meal (prior to study drug or placebo)
Serious: no
Organ System: General disorders
Notes: Related to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Tingling (paresthesia) around the mouth after intake of mixed meal (prior to study drug or placebo)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Dizzy after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Feeling unwell ("icky... drunk") after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: AE linked MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Tearful after intake of mixed meal (prior to study drug OR placebo)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Pain at pump site during MMTT (prior to delivery of study drug or placebo)
Serious: no
Organ System: General disorders
Notes: Related to study device. Resolved.
Frequency: 2 affected / 18 at risk

Adverse event: Pruritis at pump insertion site during MMTT (prior to delivery of study drug or placebo)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Irritation / pain at IV site with IV administration of dextrose
Serious: no
Organ System: General disorders
Notes: AE related to administration of D50 at placebo visit. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Tearful when IV dextrose (D50) administered
Serious: no
Organ System: General disorders
Notes: Related to MMTT \& hypoglycemia, at visit where placebo was administered. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Hypoglycemia during study (MMTT)
Serious: no
Organ System: Endocrine disorders
Notes: Related to MMTT in population understudy. Resolved.
Frequency: 13 affected / 18 at risk

Adverse event: Erythema at site of CGM sensor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to continuous glucose monitoring (CGM) device (sensor or adhesive). Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Hematoma under CGM sensor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to CGM sensor device.
Frequency: 1 affected / 18 at risk

Adverse event: Burning pain / pricking at pump site after alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE linked to placebo and study device.
Frequency: 10 affected / 18 at risk

Adverse event: Buring pain at pump site after alarm (glucagon visit)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 18 at risk

Adverse event: Erythema at pump infusion site (placebo visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to study device and placebo.
Frequency: 10 affected / 18 at risk

Adverse event: Erythema at pump infusion site (glucagon visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to study device and study drug - glucagon.
Frequency: 11 affected / 18 at risk

Adverse event: Edema at pump infusion site (placebo visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to study device and placebo.
Frequency: 4 affected / 18 at risk

Adverse event: Edema at pump infusion site (glucagon visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to study device and study drug - glucagon.
Frequency: 6 affected / 18 at risk

Adverse event: Feeling hot after alarm (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT, hypoglycemia, and delivery of study drug.
Frequency: 2 affected / 18 at risk

Adverse event: Feeling hot after alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE linked to MMTT, hypoglycemia, and delivery of placebo.
Frequency: 3 affected / 18 at risk

Adverse event: Thirsty after alarm (placebo visit)
Serious: no
Organ System: Endocrine disorders
Notes: AE linked to MMTT, hypoglycemia, and delivery of placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Nausea after alarm (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE linked to MMTT, hypoglycemia, and delivery of study drug.
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting after alarm (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant also vomited during mixed meal, prior to study drug administration. AE linked to MMTT, hypoglycemia, and delivery of study drug.
Frequency: 1 affected / 18 at risk

Adverse event: Headace after alarm (glucagon visit)
Serious: no
Organ System: General disorders
Notes: Both participants with headache following alarm also had headache prior to the alarm during mixed meal testing. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 2 affected / 18 at risk

Adverse event: Tearful during alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Confusion after alarm (placebo visit)
Serious: no
Organ System: Nervous system disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Confusion after alarm (glucagon visit)
Serious: no
Organ System: Nervous system disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Dizzy / lightheaded after alarm (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 2 affected / 18 at risk

Adverse event: Low blood pressure after alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Tiredness after alarm (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 2 affected / 18 at risk

Adverse event: Tiredness after alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Blurry vision after alarm (placebo visit)
Serious: no
Organ System: Eye disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Blurry vision after alarm (glucagon visit)
Serious: no
Organ System: Eye disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Bowel urgency after alarm (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Bowel movement after alarm (placebo visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE related to MMTT, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Stomach cramping / pain after alarm (placebo visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE related to MMTT and placebo.
Frequency: 2 affected / 18 at risk

Adverse event: Lower extremity cramping after alarm (glucagon visit)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Legs and toes cramping. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 2 affected / 18 at risk

Adverse event: Pale after alarm (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Speech slowed after alarm (placebo visit)
Serious: no
Organ System: Nervous system disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Nausea prior to lunch (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: This participant was also nauseous after intake of mixed meal, prior to receiving the study drug. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Weakness prior to lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Feeling hot prior to lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: This participant also felt hot following intake of mixed meal, prior to delivery of study drug. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Feeling hot after lunch (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, placebo.
Frequency: 2 affected / 18 at risk

Adverse event: Tiredness after lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Tiredness after lunch (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Feeling cold after lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Headache after lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 2 affected / 18 at risk

Adverse event: Stomach pains after lunch (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Nausea after lunch (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant also had nausea after intake of mixed meal, prior to delivery of study drug. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting after lunch (glucagon visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: This participant had nausea which started after intake of mixed meal, prior to study drug administration. AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Shaky following lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Ears ringing after lunch
Serious: no
Organ System: General disorders
Notes: AE related to MMTT. Resolved.
Frequency: 1 affected / 18 at risk

Adverse event: Foggy feeling after lunch (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Hypoglycemia following lunch (gluagon visit)
Serious: no
Organ System: Endocrine disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Hypoglycemia following lunch (placebo visit)
Serious: no
Organ System: Endocrine disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Back pain after lunch (placebo visit)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related. Participant with chronic back pain.
Frequency: 1 affected / 18 at risk

Adverse event: Dry mouth following alarm (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 1 affected / 18 at risk

Adverse event: Pruritis at pump site after alarm (placebo visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE related to study device and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Dizzy after discharge (placebo visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Hypoglycemia after dinner the night following the study visit (glucagon visit)
Serious: no
Organ System: Endocrine disorders
Notes: Possibly related to study visit and study drug (glucagon).
Frequency: 1 affected / 18 at risk

Adverse event: Tiredness day after study visit (placebo visit)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE related to MMTT, hypoglycemia, and placebo.
Frequency: 3 affected / 18 at risk

Adverse event: Tiredness day after study visit (glucagon visit)
Serious: no
Organ System: General disorders
Notes: AE related to MMTT, hypoglycemia, and study drug - glucagon.
Frequency: 4 affected / 18 at risk

Adverse event: Migraine headache one night following study visit (placebo visit)
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related to MMTT, hypoglycemia, and placebo.
Frequency: 1 affected / 18 at risk

Adverse event: Erythema a pump infusion site 1 day following discharge (glucagon visit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2" diameter corresponding with area of the adhesive. AE related to pump device adhesive. This participant had erythema as well documented on the day of the study visit. Resolved.
Frequency: 1 affected / 18 at risk