Study: NCT00405821

Adverse event: TB Adenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 220 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 220 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 220 at risk

Adverse event: Febrile Illness, unspecified
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 220 at risk

Adverse event: skin infection, unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: wound, unspecified
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 220 at risk

Adverse event: EENT infection, unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Bacterial pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 220 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 220 at risk

Adverse event: Extra-pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Respiratory complaint, unspecified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Abdominal pain, unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Trauma to chest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 220 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 220 at risk

Adverse event: Genito-urinary disease (GUD)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 220 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 220 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 30 affected / 220 at risk

Adverse event: Pregnancy complication, unspecified
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 220 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 220 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 107 affected / 220 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: General disorders
Frequency: 25 affected / 220 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 30 affected / 220 at risk

Adverse event: General complaint, unspecified
Serious: no
Organ System: General disorders
Frequency: 190 affected / 220 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 220 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 220 at risk

Adverse event: angular chelitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 220 at risk

Adverse event: Papulo-pruritic eruption (PPE)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 220 at risk

Adverse event: Darkening nails
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 220 at risk

Adverse event: Rash, unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 118 affected / 220 at risk

Adverse event: Skin complaint, unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 123 affected / 220 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 220 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 220 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 220 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 220 at risk

Adverse event: General complaint, unspecified
Serious: no
Organ System: General disorders
Frequency: 115 affected / 220 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 212 affected / 220 at risk

Adverse event: Respiratory complaint, unspecified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 98 affected / 220 at risk

Adverse event: HIV neuritis
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 220 at risk

Adverse event: post-herpetic neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 220 at risk

Adverse event: Nervous system, other complaint
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 220 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 220 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 220 at risk

Adverse event: Intestinal helminthiasis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 220 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 220 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 220 at risk

Adverse event: Gastrointestinal, other complaint
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 168 affected / 220 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 220 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 220 at risk

Adverse event: Musculoskeletal joint pain, unspecified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 165 affected / 220 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 220 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 220 at risk

Adverse event: Genito-urinary disease (GUD)
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 220 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 220 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 220 at risk

Adverse event: Genitourinary, other complaint
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 131 affected / 220 at risk

Adverse event: TB Adenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 220 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 220 at risk

Adverse event: Febrile Illness, unspecified
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 220 at risk

Adverse event: skin infection, unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: wound, unspecified
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 220 at risk

Adverse event: EENT infection, unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 220 at risk

Adverse event: Bacterial pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 220 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 220 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 220 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 220 at risk

Adverse event: Abdominal pain, unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 220 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 220 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 220 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 41 affected / 220 at risk

Adverse event: Pregnancy complication, unspecified
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 220 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 220 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 105 affected / 220 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: General disorders
Frequency: 36 affected / 220 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 29 affected / 220 at risk

Adverse event: General complaint, unspecified
Serious: no
Organ System: General disorders
Frequency: 187 affected / 220 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 220 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 220 at risk

Adverse event: angular chelitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 220 at risk

Adverse event: Papulo-pruritic eruption (PPE)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 220 at risk

Adverse event: Darkening nails
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 220 at risk

Adverse event: Rash, unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 119 affected / 220 at risk

Adverse event: Skin complaint, unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 122 affected / 220 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 220 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 220 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 220 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 220 at risk

Adverse event: General complaint, unspecified
Serious: no
Organ System: General disorders
Frequency: 123 affected / 220 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 212 affected / 220 at risk

Adverse event: Respiratory complaint, unspecified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 82 affected / 220 at risk

Adverse event: HIV neuritis
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 220 at risk

Adverse event: post-herpetic neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 220 at risk

Adverse event: Nervous system, other complaint
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 220 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 220 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 220 at risk

Adverse event: Intestinal helminthiasis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 220 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 220 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 220 at risk

Adverse event: Gastrointestinal, other complaint
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 157 affected / 220 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 220 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 220 at risk

Adverse event: Musculoskeletal joint pain, unspecified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 162 affected / 220 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 220 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 220 at risk

Adverse event: Genito-urinary disease (GUD)
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 220 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 220 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 220 at risk

Adverse event: Genitourinary, other complaint
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 140 affected / 220 at risk