Study: NCT00458393

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1226 at risk

Adverse event: CREATININE INCREASE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1226 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 17 affected / 1226 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1226 at risk

Adverse event: ALT INCREASE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1226 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1226 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1226 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 1226 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1226 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1226 at risk

Adverse event: OTHER EVENTS
Serious: yes
Organ System: General disorders
Notes: EVENTS AFFECTING LESS THAN A TOTAL OF 5 PARTICIPANTS
Frequency: 28 affected / 1226 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 248 affected / 1226 at risk

Adverse event: Parasitic gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 231 affected / 1226 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 151 affected / 1226 at risk

Adverse event: BILIRUBIN INCREASE
Serious: no
Organ System: Investigations
Frequency: 127 affected / 1226 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 109 affected / 1226 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 109 affected / 1226 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 122 affected / 1226 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 1226 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 98 affected / 1226 at risk

Adverse event: Urethritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 84 affected / 1226 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 84 affected / 1226 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 76 affected / 1226 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 1226 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 1226 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 1226 at risk

Adverse event: Secondary syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 1226 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1226 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 1230 at risk

Adverse event: CREATININE INCREASE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 1230 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 1230 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 1230 at risk

Adverse event: ALT INCREASE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1230 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1230 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1230 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 1230 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 1230 at risk

Adverse event: OTHER EVENTS
Serious: yes
Organ System: General disorders
Notes: EVENTS AFFECTING LESS THAN A TOTAL OF 5 PARTICIPANTS
Frequency: 29 affected / 1230 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 282 affected / 1230 at risk

Adverse event: Parasitic gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 216 affected / 1230 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 155 affected / 1230 at risk

Adverse event: BILIRUBIN INCREASE
Serious: no
Organ System: Investigations
Frequency: 132 affected / 1230 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 1230 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 123 affected / 1230 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 100 affected / 1230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 1230 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 92 affected / 1230 at risk

Adverse event: Urethritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 102 affected / 1230 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 87 affected / 1230 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 93 affected / 1230 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 1230 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 1230 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 1230 at risk

Adverse event: Secondary syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 1230 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1230 at risk