TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00746356

Adverse event: ecchymosis at implant site
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse events are reported as either a complication or observation (1), defined as an adverse event that requires invasive intervention or an adverse event that can be managed without invasive intervention, respectively.
Frequency: 1 affected / 128 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: 7 observations
Frequency: 7 affected / 128 at risk

Adverse event: LV lead dislodgement
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: erroneous elective replacement alert
Serious: no
Organ System: Surgical and medical procedures
Notes: 3 observations
Frequency: 3 affected / 128 at risk

Adverse event: high defibrillation thresholds
Serious: no
Organ System: Cardiac disorders
Notes: 1 observation
Frequency: 1 affected / 128 at risk

Adverse event: Infection
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication, 1 observation
Frequency: 2 affected / 128 at risk

Adverse event: suspected set screw malfunction
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: suspected generator malfunction
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: elevated pacing thresholds - RA lead
Serious: no
Organ System: Cardiac disorders
Notes: 1 observation
Frequency: 1 affected / 128 at risk

Adverse event: elevated pacing thresholds - RV lead
Serious: no
Organ System: Cardiac disorders
Notes: 1 complication, 1 observation
Frequency: 2 affected / 128 at risk

Adverse event: elevated pacing threshold - LV lead
Serious: no
Organ System: Cardiac disorders
Notes: 9 observations, 9 pts
Frequency: 9 affected / 128 at risk

Adverse event: lead dislodgement/migration - RA lead
Serious: no
Organ System: Surgical and medical procedures
Notes: 2 complications - 2 pts
Frequency: 2 affected / 128 at risk

Adverse event: lead dislodgement/migration - RV lead
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: lead dislodgement/migration - LV lead
Serious: no
Organ System: Surgical and medical procedures
Notes: 4 complications, 3 pts
Frequency: 3 affected / 128 at risk

Adverse event: lead insulation damage - RV lead
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 complication
Frequency: 1 affected / 128 at risk

Adverse event: phrenic nerve/diaphragmatic stimulation - LV lead
Serious: no
Organ System: Surgical and medical procedures
Notes: 4 observations, 1 complication
Frequency: 5 affected / 128 at risk

Adverse event: RA and RV lead dislodgement/migration
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 observation
Frequency: 1 affected / 128 at risk
Study: NCT00746395

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT00746421

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 12 at risk
Study: NCT00746512

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chronic Obstructive Pumonary Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Arthalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT00746564

Adverse event: PREMATURE BATTERY DEPLETION/ ICM
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 75 at risk

Adverse event: Device extrusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 75 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 75 at risk

Adverse event: EARLY BATTERY DEPLETION/ PATIENT ACTIVATOR
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 75 at risk

Adverse event: Excessive Noise on the EGM Resulting in Inability to Interpret the EGM
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 75 at risk

Adverse event: Undersensing
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 75 at risk
Study: NCT00746590

Adverse event: GI toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient developed GI toxicity resulting in hospitalization considered to be possibly related to study treatment and manifested by dehydration, nausea, anorexia, fatigue, vomiting, diarrhea, and deterioration in performance status (ECOG 3).
Frequency: 1 affected / 1 at risk
Study: NCT00746603

Adverse event: Blood creatine phosphokinase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: S #1 at CHOP had increased CK:did not meet adverse event criteria. Later admitted to taking Androgel, not a study exclusion criteria but similar to a drug that was. PI at CHOP made decision to remove patient from study. Repeat CK wnl.
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: S#2 at CHOP developed rash, chose to stop taking medication.
Frequency: 1 affected / 3 at risk
Study: NCT00746694

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 154 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 154 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 154 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 154 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 154 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 154 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 154 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 154 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 61 affected / 154 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 154 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 154 at risk
Study: NCT00746733

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 21 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 21 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 21 at risk
Study: NCT00746785

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Orthostasis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diabetic Episode
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal pain/palpable mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk
Study: NCT00746863

Adverse event: Transfusion
Serious: no
Organ System: Surgical and medical procedures
Notes: One patient in the Intervention group - Marcaine, required a blood transfusion postoperatively secondary to low starting hematocrit preoperatively.
Frequency: 1 affected / 21 at risk

Adverse event: Labial hematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: One patient in the Intervention group - Marcaine, had a labial hematoma noted postoperatively, this self-limited and resolved spontaneously
Frequency: 1 affected / 21 at risk

Adverse event: Hip pain
Serious: no
Organ System: Surgical and medical procedures
Notes: One patient in the Intervention group - Marcaine, complained of right hip pain on postoperative day 1. This resolved with conservative measures.
Frequency: 1 affected / 21 at risk

Adverse event: Prolonged voiding dysfunction
Serious: no
Organ System: Renal and urinary disorders
Notes: One patient in the Control group - No marcaine, had prolonged incomplete emptying and had a release of her sling 6 weeks after her initial surgery.
Frequency: 1 affected / 21 at risk
Study: NCT00747149

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 319 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 319 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 232 at risk

Adverse event: Chemical poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 232 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 232 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 279 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 279 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 279 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 182 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk
Study: NCT00747214

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Femoral hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Left femoral hernia that required hospitalization and surgical correction. In the opinion of the investigator this event was not related to study drug.
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk
Study: NCT00747227

Adverse event: Retinal Tear requiring secondary surgical intervention
Serious: yes
Organ System: Eye disorders
Notes: Secondary surgical intervention required to repair adverse event of retinal tear. Principal Investigators felt it unlikely retinal tear was lens-related and both adverse events were reported as resolved with sequelae.
Frequency: 1 affected / 126 at risk

Adverse event: Retinal Tear requiring secondary surgical intervention
Serious: yes
Organ System: Eye disorders
Notes: Secondary surgical intervention required to repair adverse event of retinal tear. Principal Investigators felt it unlikely retinal tear was lens-related and both adverse events were reported as resolved with sequelae.
Frequency: 1 affected / 124 at risk
Study: NCT00747435

Adverse event: Profound/total loss of residual hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 73 at risk

Adverse event: Electrode migration
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 73 at risk

Adverse event: Electrode lead breakage
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Excess micro-movements caused by subject
Frequency: 1 affected / 73 at risk

Adverse event: Type B/Type C tympanogram
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 73 at risk

Adverse event: Conductive deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 73 at risk

Adverse event: Pain at implant site
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 73 at risk
Study: NCT00747565

Adverse event: Endophthalmitis, hypopyon and surgical intervention
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 348 at risk

Adverse event: Signifcant loss in vision due to stroke
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 348 at risk

Adverse event: Lens-related lens removal
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 348 at risk

Adverse event: Lens-related other surgical procedures
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 348 at risk

Adverse event: Non-lens-related lens exchange
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 348 at risk

Adverse event: Non-lens-related other surgical procedures
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 348 at risk

Adverse event: Non-lens-related other surgical procedures
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 123 at risk
Study: NCT00747747

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT00748033

Adverse event: Discomfort during insertion of test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 24 at risk

Adverse event: Discomfort during withdrawal of test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 24 at risk

Adverse event: Discomfort during micturition after test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 24 at risk

Adverse event: Discomfort during insertion of test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 25 at risk

Adverse event: Discomfort during withdrawal of test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 25 at risk

Adverse event: Discomfort during micturition after test catheter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hematuria after test catheter is removed
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk
Study: NCT00748072

Adverse event: mild increase of heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 80 at risk
Study: NCT00748085

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: other-Hoarseness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT00748098

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 132 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 132 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 132 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 132 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 132 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 132 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 127 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 127 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 127 at risk
Study: NCT00748241

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk
Study: NCT00748410

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Sensation of brick in stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk