Study: NCT02563769

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Two occurrences in one subject: 3 consecutive ventricular complexes on day 1 and 4 consecutive beats ventricular complexes on day of CLAV 500mg dose
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal gas
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 events in 2 subjects; one subject had event on day 1 and CLAV 250mg day. The 2nd subject's event was on discharge day
Frequency: 1 affected / 10 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lower eyelid twitch rhythmic
Serious: no
Organ System: Eye disorders
Notes: Right eye only
Frequency: 1 affected / 10 at risk

Adverse event: Lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject, 4 events
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness was located near IV injection site
Frequency: 1 affected / 10 at risk

Adverse event: Elevated calcium levels
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject, 4 events
Frequency: 1 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal gas
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 events in 2 subjects; one subject had event on day 1 and CLAV 250mg day. The 2nd subject's event was on discharge day
Frequency: 1 affected / 10 at risk

Adverse event: Nausea+vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 events in 1 subject--after CLAV 250mg and CLAV 500mg
Frequency: 1 affected / 10 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lightheaded
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject, 4 events
Frequency: 1 affected / 10 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Two occurrences in one subject: 3 consecutive ventricular complexes on day 1 and 4 consecutive beats ventricular complexes on day of CLAV 500mg dose
Frequency: 1 affected / 10 at risk

Adverse event: Nausea+vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 events in 1 subject--after CLAV 250mg and CLAV 500mg
Frequency: 1 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated calcium levels
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 3 subject, 4 events; one subject had headache on day 5 (CLAV 750mg) and day 6 (discharge day)
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 3 subject, 4 events; one subject had headache on day 5 (CLAV 750mg) and day 6 (discharge day)
Frequency: 2 affected / 5 at risk

Adverse event: Abdominal gas
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 events in 2 subjects; one subject had event on day 1 and CLAV 250mg day. The 2nd subject's event was on discharge day
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 3 subject, 4 events; one subject had headache on day 5 (CLAV 750mg) and day 6 (discharge day)
Frequency: 1 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: upper respiratory infection (URI)
Serious: no
Organ System: Infections and infestations
Notes: one with upper respiratory infection; one with flu
Frequency: 2 affected / 10 at risk

Adverse event: Reaction to Telemetry Pads on Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hand bilateral spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk