Study: NCT03848728

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 4 affected / 1012 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 2 affected / 1012 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 8 affected / 1012 at risk

Adverse event: Injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Cesarean infant delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 2 affected / 1012 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 5 affected / 1012 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Suspected bacterial or tubercular respiratory infection resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1012 at risk

Adverse event: Liver disease resulting in death
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Presumed sepsis resulting in death
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Respiratory failure resulting in death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1012 at risk

Adverse event: Hepatocellular carcinoma resulting in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1012 at risk

Adverse event: Death, cause unknown
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1012 at risk

Adverse event: Suspected tuberculosis resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1012 at risk

Adverse event: Severe anemia resulting in death
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Pulmonary tuberculosis resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1012 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Notes: Serious Adverse Events not resulting in death were not monitored/assessed in the control arm.
Frequency: 1 affected / 1012 at risk

Adverse event: CNS-TB with possible brain tumor resulting in death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Renal failure resulting in death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1012 at risk

Adverse event: Abdominal tumor resulting in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1012 at risk

Adverse event: Pre-eclampsia toxemia resulting in death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1012 at risk

Adverse event: Death, cause unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 976 at risk

Adverse event: Severe anemia resulting in death
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 976 at risk

Adverse event: AIDS resulting in death
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 976 at risk

Adverse event: Kidney disease resulting in death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 976 at risk

Adverse event: Sickle cell anemia resulting in death
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 976 at risk

Adverse event: Severe malnutrition resulting in death
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 976 at risk

Adverse event: Pulmonary tuberculosis resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 976 at risk

Adverse event: Organ failure, cause unknown, resulting in death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 976 at risk

Adverse event: Kaposi sarcoma resulting in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 976 at risk

Adverse event: Pneumonia resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 976 at risk

Adverse event: Complications following Cesarean childbirth resulting in death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 976 at risk