Study: NCT02509481

Adverse event: moderate to severe malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1265 at risk

Adverse event: Neonatal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1265 at risk

Adverse event: untreated decompensated hypertensive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1265 at risk

Adverse event: fever, vomiting, anorexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1265 at risk

Adverse event: Infectious pneumopathy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1265 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1265 at risk

Adverse event: acute malnutrition
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1265 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1265 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1265 at risk

Adverse event: unspecified injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1265 at risk

Adverse event: stage 3 tooth decay with local tumefaction
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1265 at risk

Adverse event: Bilateral palpebral edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1265 at risk

Adverse event: Tremor, palpitations, arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1265 at risk

Adverse event: Perforated bilaterally suppurated otitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1265 at risk

Adverse event: Pruritus
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1265 at risk

Adverse event: snakebite envenomation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1265 at risk

Adverse event: intercostal zoster from immune system depression
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1265 at risk

Adverse event: moderate to severe malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1447 at risk

Adverse event: acute intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: liver disease: ascites + bulky edema of the lower limbs.
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1447 at risk

Adverse event: liver cancer, cirrhosis of the liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1447 at risk

Adverse event: abdominal pain, loose stool, vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: fever, anemia, cachexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1447 at risk

Adverse event: severe sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1447 at risk

Adverse event: unspecified sudden death in the early morning
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1447 at risk

Adverse event: vomiting, hematemesis, bloody stool, cardiovascular shock
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: Abdominal bloating, fecal matter obstruction, anuria, refusal to breastfeed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: fever and chills; suspected typhoid fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1447 at risk

Adverse event: snakebite envenomation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1447 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1447 at risk

Adverse event: acute malnutrition
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1447 at risk

Adverse event: Pruritus
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 1447 at risk

Adverse event: acute otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1447 at risk

Adverse event: febrile diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: first degree burn over 80% of lower right limb
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1447 at risk

Adverse event: suppurative otitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1447 at risk

Adverse event: unspecified injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1447 at risk

Adverse event: Involuntary abortion at two months of pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1447 at risk

Adverse event: road accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1447 at risk

Adverse event: Chronic wound in the left ankle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1447 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1447 at risk

Adverse event: Postpartum pelvic pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1447 at risk

Adverse event: Abdominal pain, loose stool, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1447 at risk

Adverse event: headache and chills; suspected infectious origin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1447 at risk

Adverse event: Swelling of the feet, hyperthermia and chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1447 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1447 at risk

Adverse event: fever and chills; suspected typhoid
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1447 at risk