Study: NCT01331330

Adverse event: Overdose of Diathipin and Valium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dental abscess (lower jaw on the left side)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Episode of anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Scalp itching under the head bandage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sensation (tingling) in different parts of the face on touching the scalp
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sore throat, fever, lethargy, drowsiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Burning sensation over the chest scar
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Itching and pain at the site of the surgical incision in the chest on moving the left arm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Pain (neuralgia) over the left tempromadipular joint and extended to left scalp
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Pollakiury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal upset and tremors
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal upset, hyperacidity and diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhea and vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness and losing balance (otitis media)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: First of 2 falls
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Frontal headache on the left side
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Itching at the front hairline
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Itching of the scalp, when the head bandage was on
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Losing balance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Poor memory to recent events
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Second of 2 falls
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Tightness in the neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood oozing (bleeding) from the incision on the left side of the scalp
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Mild headache at the site of the incisions in the scalp
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Mild pain and tenderness at left upper side of the chest (battery site)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Pain and tenderness at the site of the chest incision
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Post operative headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Post surgical headache (mainly in the forehead, throbbing in nature)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Redness and mild swelling at the site of the left scalp incision and chest incision
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Redness and swelling at the site of the chest incision
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Stabbing pain at the site of the chest surgical incision
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Tenderness at the left side of the scalp when the patient lies down on that side
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Throbbing sensation at the site of the right scalp incision
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Aching pain over the middle 3 fingers and palm of the right hand
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vibration at the top left end of the ipg
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 4 at risk

Adverse event: Oesophageal irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sore throat (upper respiratory tract infection)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk