Study: NCT01721798

Adverse event: Low CD4 count
Serious: yes
Organ System: Immune system disorders
Notes: In keeping with the South Africa's 2015 guideline for initiation of ART based on CD4\<=500, participant's CD4 count necessitated ART referral under new clinical guidelines.
Frequency: 9 affected / 36 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hernia Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk

Adverse event: Liver failure/injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 36 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 36 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 36 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 36 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 36 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 31 at risk

Adverse event: Low CD4 count
Serious: yes
Organ System: Immune system disorders
Notes: In keeping with the South Africa's 2015 guideline for initiation of ART based on CD4\<=500, participant's CD4 count necessitated ART referral under new clinical guidelines.
Frequency: 5 affected / 31 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pregnancy with IUD in place
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 31 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Car accident- Broken Leg - Hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 31 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 31 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 31 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 31 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 31 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 65 at risk

Adverse event: Pregnancy with IUD in place
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 65 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Death - possibly injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Accident - Broken Leg - Hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Abscess/Vagina Labia Majora
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 65 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 65 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 65 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 65 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 65 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 65 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 65 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 65 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 65 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 65 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 65 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Right Tubal Ectopic Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 67 at risk

Adverse event: Admission to psychiatric hospital
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: Death - unknown reasons
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: IUD expulsion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 67 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 67 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 67 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 67 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 67 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 67 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 67 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 67 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 67 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 67 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 67 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 67 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Low CD4 count
Serious: yes
Organ System: Immune system disorders
Notes: In keeping with the South Africa's 2015 guideline for initiation of ART based on CD4\<=500, participant's CD4 count necessitated ART referral under new clinical guidelines.
Frequency: 9 affected / 101 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 101 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 101 at risk

Adverse event: Pregnancy with IUD in place
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 101 at risk

Adverse event: Hernia Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Death - possibly injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Liver failure/injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Accident - Broken Leg - Hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Abscess/Vagina Labia Majora
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 101 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 101 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 101 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 101 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 29 affected / 101 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 101 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 101 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 101 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 101 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 101 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 11 affected / 101 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 101 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 98 at risk

Adverse event: Low CD4 count
Serious: yes
Organ System: Immune system disorders
Notes: In keeping with the South Africa's 2015 guideline for initiation of ART based on CD4\<=500, participant's CD4 count necessitated ART referral under new clinical guidelines.
Frequency: 5 affected / 98 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pregnancy with IUD in place
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 98 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Car accident- Broken Leg - Hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Right Tubal Ectopic Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 98 at risk

Adverse event: Admission to psychiatric hospital
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Death - unknown reasons
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: IUD expulsion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 98 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 98 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 98 at risk

Adverse event: Irregular/heavy uterine bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 98 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 98 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 98 at risk

Adverse event: Enlarged Abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 98 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 98 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 98 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 98 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 13 affected / 98 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 98 at risk