Study: NCT02558829

Adverse event: Upper limp fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The patient had underwent an ITT on July 5 and the macimorelin GHST on July 12, 2016. On July 13, the patient fell of a ladder accidentally and broke his left arm. Causality reported by investigator: unrelated to study treatment.
Frequency: 1 affected / 154 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 154 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 154 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 154 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 154 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 5 affected / 154 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 154 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 2 affected / 154 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Upper limp fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The patient had underwent an ITT on July 5 and the macimorelin GHST on July 12, 2016. On July 13, the patient fell of a ladder accidentally and broke his left arm. Causality reported by investigator: unrelated to study treatment.
Frequency: 1 affected / 157 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 157 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 157 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 157 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 157 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 46 affected / 157 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 157 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 157 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 157 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 105 affected / 157 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 157 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 157 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 6 affected / 157 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 44 affected / 157 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 12 affected / 157 at risk