Study: NCT02927236

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 19 at risk

Adverse event: tactile hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: one participant had the sensation of muscle twitching without any twitching several hours after an iTBS session. One experienced cocaine induced tactile hallucinations for the first time during the course of treatment.
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: hang nail bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Amnesia
Serious: no
Organ System: Psychiatric disorders
Notes: participant reported memory difficulties during a first date with someone he'd interacted online with for months and after a few beers. Resolved after the date.
Frequency: 1 affected / 19 at risk

Adverse event: muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: food poisoning
Frequency: 1 affected / 19 at risk

Adverse event: tooth and ear pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: recurrence of tooth pain and tooth pain radiating to ear and unrelated to study.
Frequency: 2 affected / 19 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Right hand tremor after iTBS
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Eye pain during iTBS stimulation
Frequency: 1 affected / 3 at risk

Adverse event: Nervous system- other
Serious: no
Organ System: Nervous system disorders
Notes: participant reported nightmares related to the drug cues presented during iTBS.
Frequency: 1 affected / 3 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Participant reported red wine-colored urine, likely related to consumption of beets and rhubarb.
Frequency: 1 affected / 3 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant experienced broken cuticles on fingers of right hand related to his underlying eczema.
Frequency: 1 affected / 3 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Right hand tremor after iTBS
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: scalp pain under TMS coil during stimulation, as expected.
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nervous system- other
Serious: no
Organ System: Nervous system disorders
Notes: Muscle twitching under transcranial magnetic stimulation (TMS) coil during stimulation, as expected.
Frequency: 1 affected / 19 at risk

Adverse event: tactile hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: one participant had the sensation of muscle twitching without any twitching several hours after an iTBS session. One experienced cocaine induced tactile hallucinations for the first time during the course of treatment.
Frequency: 1 affected / 19 at risk