TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00963599

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancies are not considered serious adverse events, however, they are collected in a similar manner so that they are learned of quickly and are followed to outcome. Therefore they appear as an event in our SAE reporting tables.
Frequency: 1 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 301 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 302 at risk
Study: NCT00963807

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT00963859

Adverse event: Bowel Leak
Serious: yes
Organ System: Surgical and medical procedures
Notes: Bowel leak from the gastrointestinal anastomosis
Frequency: 1 affected / 11 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk
Study: NCT00963924

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was hospitalized due to worsening psychiatric symptoms.
Frequency: 1 affected / 18 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 18 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 18 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

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

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 18 at risk
Study: NCT00963937

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 74 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 74 at risk
Study: NCT00963989

Adverse event: Carotid artery dissection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral vasoconstriction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Vessel perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 146 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral artery embolism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Cerebral vasoconstriction
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 146 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Vascular dissection
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk
Study: NCT00964002

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 59 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Aortic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk
Study: NCT00964028

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 15 affected / 25 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 25 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk
Study: NCT00964119

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (full body questionnaire)
Frequency: 8 affected / 15 at risk
Study: NCT00964353

Adverse event: DVT or PE
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 181 at risk

Adverse event: DVT or PE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk
Study: NCT00964366

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One subject on the clinicamycin/BPO arm was reported to have a headache and one subject on the dapsone arm was reported to have a migrane headache. Neither of these was reported as being related to the study drug by the investigator.
Frequency: 1 affected / 27 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: One subject had a urinary tract infeaction in the dapsone treatment group and one subject had a vaginal yeast infection on the clindamycin/ BPO treatment group. Neither of these was reported as being related to the study drug by the investigator.
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One subject on the clinicamycin/BPO arm was reported to have a headache and one subject on the dapsone arm was reported to have a migrane headache. Neither of these was reported as being related to the study drug by the investigator.
Frequency: 1 affected / 25 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: One subject had a urinary tract infeaction in the dapsone treatment group and one subject had a vaginal yeast infection on the clindamycin/ BPO treatment group. Neither of these was reported as being related to the study drug by the investigator.
Frequency: 1 affected / 25 at risk
Study: NCT00964548

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Hypotension during infusion due to vasopressor infusion stop (ran out during infusion, leading to BP drop).
Frequency: 1 affected / 5 at risk
Study: NCT00964678

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: mild, resolved with dose reduction and slow rate of titration
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: asymptomatic. Mild, resolved with dose reduction
Frequency: 1 affected / 6 at risk
Study: NCT00964743

Adverse event: Death not associated with CTCAE term - Death not otherwise specified (NOS)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Death occurred within 30 days. Unrelated to study treatment. Death not associated with Common Terminology Criteria for Adverse Events (CTCAE)
Frequency: 1 affected / 2 at risk

Adverse event: Death not associated with CTCAE term - Disease progression not otherwise specified (NOS)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Death occurred within 30 days. Unrelated to study treatment. Death not associated with Common Terminology Criteria for Adverse Events (CTCAE)
Frequency: 1 affected / 2 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L
Serious: no
Organ System: General disorders
Notes: Grade 1. Unrelated. Fever (in the absence of neutropenia, where neutropenia is defined as absolute neutrophil count (ANC) \<1.0 x 10\^9/L
Frequency: 1 affected / 2 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Infection with unknown ANC-Mucosa
Serious: no
Organ System: Infections and infestations
Notes: Grade 1. Unrelated. Infection with unknown absolute neutrophil count (ANC)-Mucosa
Frequency: 1 affected / 2 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2. Unrelated.
Frequency: 1 affected / 2 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1. Unrelated
Frequency: 1 affected / 2 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3. Unrelated.
Frequency: 1 affected / 2 at risk
Study: NCT00964782

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT00965146

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Infection and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 210 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders (Non-operative site)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorder (Operative Site)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 210 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders - (Operative Site)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 210 at risk
Study: NCT00965185

Adverse event: Fallopian tube cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal virus induced dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Muscle aches or cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 19 at risk

Adverse event: Liver function test abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Notes: Greater than or equal to three times upper limit of normal
Frequency: 3 affected / 19 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Muscle aches or cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Liver function test abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Notes: Greater than or equal to three times upper limit of normal
Frequency: 2 affected / 21 at risk

Adverse event: Elevated fasting blood glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Greater than 126 mg/dL
Frequency: 2 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk
Study: NCT00965341

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pain (NOS)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Neuropathy: Sensory
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infection (Other)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neuropathy: Cranial
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain (Other)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain (Skin)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pain (NOS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk
Study: NCT00965419

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Intentional product misuse
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 264 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 264 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 264 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 264 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 264 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 264 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 264 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 264 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 264 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 264 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 264 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 264 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 80 at risk
Study: NCT00965497

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk
Study: NCT00965562

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

Adverse event: Muscle spasms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Feeling spacy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Abdominal ache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decreased sex drive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk