TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00035815

Adverse event: Thrombotic events
Serious: yes
Organ System: Vascular disorders
Notes: Serious thrombotic events
Frequency: 18 affected / 167 at risk

Adverse event: Site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 88 affected / 167 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 167 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 167 at risk

Adverse event: Change in visual acuity
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 167 at risk

Adverse event: Abnormal blood chemistries (other than liver)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 167 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 167 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 103 affected / 167 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 167 at risk

Adverse event: Thrombotic events
Serious: yes
Organ System: Vascular disorders
Notes: Serious thrombotic events
Frequency: 12 affected / 163 at risk

Adverse event: Site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 92 affected / 163 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 163 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 163 at risk

Adverse event: Change in visual acuity
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 163 at risk

Adverse event: Abnormal blood chemistries (other than liver)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 163 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 163 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 92 affected / 163 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 163 at risk
Study: NCT00036738

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk
Study: NCT00038675

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 125 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Herniated disc Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 125 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Second Malignancy (Basal Cell Carcinoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk
Study: NCT00038727

Adverse event: Any SAE Report
Serious: yes
Organ System: General disorders
Frequency: 472 affected / 916 at risk

Adverse event: Sprains and fractures requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 234 affected / 916 at risk

Adverse event: Any SAE Report
Serious: yes
Organ System: General disorders
Frequency: 482 affected / 927 at risk

Adverse event: Sprains and fractures requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 274 affected / 927 at risk

Adverse event: Any SAE Report
Serious: yes
Organ System: General disorders
Frequency: 492 affected / 936 at risk

Adverse event: Sprains and fractures requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 257 affected / 936 at risk
Study: NCT00040742

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 188 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 188 at risk

Adverse event: Pulmonary disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Bruising/flushing, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 183 at risk

Adverse event: Pulmonary disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Cerebral disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Weakness, dizziness, fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 187 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Blood disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 187 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 187 at risk

Adverse event: Bruising/flushing, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 187 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 187 at risk
Study: NCT00041470

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Infections and infestations
Notes: Requiring total parenteral nutrition
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk
Study: NCT00043550

Adverse event: passive suicide attempt
Serious: no
Organ System: Psychiatric disorders
Notes: patient reported taking 4.5 mg of alprazolam . An hour later he took venlafaxine 187.5 mg, methylphenidate 30mg, and oxycodone 5mg with acetominophen. Patient was taken to the hospital ER and released without medical intervention.
Frequency: 1 affected / 51 at risk
Study: NCT00044655

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Following medication change, participant's prescriber called Project Director to report that the participant was not doing well and was hospitalized subsequent to symptom exacerbation; prescriber changed client's antipsychotic medication regime.
Frequency: 1 affected / 117 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Site PI learned that the 69 year old participant had died following recurrent episodes of bleeding from cerebral aneurism that was diagnosed, but unknown to the site PI, prior to study enrollment (randomized to injectable risperidone)
Frequency: 1 affected / 117 at risk
Study: NCT00045110

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 32 at risk

Adverse event: Granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk
Study: NCT00045435

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 17 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk
Study: NCT00045487

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hand-Foot Syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: PT Prolongation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk
Study: NCT00045734

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 22 at risk

Adverse event: CNS (intracranial) Hemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: dehydrations
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: elevated serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk
Study: NCT00047385

Adverse event: Nausea/vomiting, bradycardia, diaphoresis
Serious: yes
Organ System: General disorders
Notes: Transient syncope w/ vomiting/bradycardia/diaphoresis/ashen color after phlebotomy and single forced expiration for spirometry.

Hospitalized for monitoring; MI ruled out. Recovered with time, rest, and liquids.
Frequency: 1 affected / 26732 at risk

Adverse event: Cardiac symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: Shortness of breath, diaphoresis, jaw pain and general cardiac symptoms. Admitted to hospital; MI ruled out. Treated with medication/inhalers for COPD exacerbation. Stable through the admission; fully recovered the following day.
Frequency: 1 affected / 26732 at risk
Study: NCT00047463

Adverse event: tachycardia or chest tightness
Serious: no
Organ System: Cardiac disorders
Notes: patient described a rapid heart rate
Frequency: 1 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: anxious using CPAP
Frequency: 1 affected / 13 at risk

Adverse event: tachycardia or chest tightness
Serious: no
Organ System: Cardiac disorders
Notes: patient described a rapid heart rate
Frequency: 1 affected / 22 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation at site of CPAP mask
Frequency: 2 affected / 22 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: nasal congestion for CPAP use
Frequency: 1 affected / 22 at risk

Adverse event: GI discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal discomfort after use of CPAP
Frequency: 1 affected / 22 at risk
Study: NCT00047879

Adverse event: Metabolic, hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Elevated AST
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Metabolic, ALT elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Pain, skin
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

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

Adverse event: Neurology, somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Musculoskeletal, other leg/foot cramp
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: edema: limb right upper extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT00048347

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients reported fever (63%) and mild flu-like symptoms (myalgias in 31%) after injections, but these were transient (usually resolving 4-5 hours after the injection) and responded well to treatment with acetominophen.
Frequency: 10 affected / 16 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: paresthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pilonidal disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: palmar xeroderma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: C. difficile colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT00048997

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 163 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Mood alteration-depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 163 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 163 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 163 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 51 affected / 163 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 27 affected / 163 at risk

Adverse event: Late RT Toxicity: Skin: NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 163 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 163 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 163 at risk

Adverse event: Late RT Toxicity: Brain: NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 163 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 163 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 163 at risk
Study: NCT00049504

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 55 at risk

Adverse event: Graft-versus-host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Secondary myeloid malignancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Invasive Fungal Infection
Serious: no
Organ System: Infections and infestations
Notes: Proven or probable invasive fungal infections
Frequency: 6 affected / 55 at risk

Adverse event: CMV reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 34 at risk

Adverse event: Recurrent or progressive malignancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 55 at risk
Study: NCT00052078

Adverse event: Worsening of Behavior
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant in the sertraline group had a worsening of behavior that was attributed to the parents' increased limit setting on avoidance behavior; the event was considered to be possibly related to sertraline.
Frequency: 1 affected / 133 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: One participant in the sertraline group was medically hospitalized for a tonsillectomy. This event was considered unrelated to study treatment.
Frequency: 1 affected / 133 at risk

Adverse event: Oppositional-Defiant Behavior
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant in the combination-therapy group had a worsening of preexisting oppositional-defiant behavior that resulted in psychiatric hospitalization; this event was considered to be unrelated to study treatment.
Frequency: 1 affected / 140 at risk