Trial Outcomes & Findings for Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study (NCT NCT01360762)
NCT ID: NCT01360762
Last Updated: 2019-02-15
Results Overview
Probability of relapse-free survival up to one year after the start of the intervention (PSP) (at month 6 and month 12)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
up to 1 year after the start of the intervention (PSP)
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Main Study Period (12-month Treatment)
STARTED
|
74
|
|
Main Study Period (12-month Treatment)
COMPLETED
|
45
|
|
Main Study Period (12-month Treatment)
NOT COMPLETED
|
29
|
|
Whole Study Period
STARTED
|
74
|
|
Whole Study Period
COMPLETED
|
38
|
|
Whole Study Period
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Main Study Period (12-month Treatment)
Lost to Follow-up
|
7
|
|
Main Study Period (12-month Treatment)
Death
|
5
|
|
Main Study Period (12-month Treatment)
Discontinuation of study drug for safety
|
1
|
|
Main Study Period (12-month Treatment)
Patient relapsed
|
15
|
|
Main Study Period (12-month Treatment)
Discontinuation
|
1
|
|
Whole Study Period
Lost to Follow-up
|
10
|
|
Whole Study Period
Death
|
7
|
|
Whole Study Period
Patient relapsed
|
18
|
|
Whole Study Period
Discontinuation of study drug for safety
|
1
|
Baseline Characteristics
Information for one participant is missing.
Baseline characteristics by cohort
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Age, Continuous
|
32 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=74 Participants
|
|
Weight
|
50 kg
n=74 Participants
|
|
Body Mass Index (BMI)
BMI < 18.5 kg/m^2
|
56 Participants
n=74 Participants
|
|
Body Mass Index (BMI)
BMI > 18.5 kg/m^2
|
18 Participants
n=74 Participants
|
|
Functional status
Working
|
46 Participants
n=73 Participants • Information for one participant is missing.
|
|
Functional status
Ambulatory
|
25 Participants
n=73 Participants • Information for one participant is missing.
|
|
Functional status
Bed ridden
|
2 Participants
n=73 Participants • Information for one participant is missing.
|
|
Spleen size
not palpable
|
30 Participants
n=73 Participants • 1 Subjects had no spleen size calculation due to ascites.
|
|
Spleen size
Palpable < 5 cm
|
14 Participants
n=73 Participants • 1 Subjects had no spleen size calculation due to ascites.
|
|
Spleen size
Palpable 5 cm or > 5 cm
|
29 Participants
n=73 Participants • 1 Subjects had no spleen size calculation due to ascites.
|
|
Total liver span
|
11 cm
n=74 Participants
|
|
Total WBC count
|
3000 cells/µL
n=74 Participants
|
|
Neutrophil percent
|
62.3 percentage of neutrophils
n=74 Participants
|
|
Lymphocyte percent
|
27.8 percentage of lymphocytes
n=74 Participants
|
|
Haemoglobin
|
9.2 g/dL
n=74 Participants
|
|
Platelet count
|
192 platelets x10^3 / µL
n=74 Participants
|
|
Current CD4 count
|
127 cells/µL
n=74 Participants
|
|
Current CD4 count
50 or less
|
7 Participants
n=74 Participants
|
|
Current CD4 count
51-100
|
15 Participants
n=74 Participants
|
|
Current CD4 count
101-200
|
37 Participants
n=74 Participants
|
|
Current CD4 count
201-350
|
7 Participants
n=74 Participants
|
|
Current CD4 count
more than 350
|
5 Participants
n=74 Participants
|
|
Current CD4 count
Missing
|
3 Participants
n=74 Participants
|
|
VL status
Primary
|
31 Participants
n=74 Participants
|
|
VL status
Relapse
|
43 Participants
n=74 Participants
|
|
Number of VL episodes before inclusion
1 episode
|
27 Participants
n=43 Participants • There were only 43 subjects out of the 74 total population that were relapse subjects. The other 31 subjects had a primary infection
|
|
Number of VL episodes before inclusion
2 episodes
|
12 Participants
n=43 Participants • There were only 43 subjects out of the 74 total population that were relapse subjects. The other 31 subjects had a primary infection
|
|
Number of VL episodes before inclusion
3 episodes
|
3 Participants
n=43 Participants • There were only 43 subjects out of the 74 total population that were relapse subjects. The other 31 subjects had a primary infection
|
|
Number of VL episodes before inclusion
4 episodes
|
1 Participants
n=43 Participants • There were only 43 subjects out of the 74 total population that were relapse subjects. The other 31 subjects had a primary infection
|
PRIMARY outcome
Timeframe: up to 1 year after the start of the intervention (PSP)Probability of relapse-free survival up to one year after the start of the intervention (PSP) (at month 6 and month 12)
Outcome measures
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Probability of Relapse-free Survival
Probability of relapse-free survival at 6 months
|
79 percentage probability
Interval 67.0 to 87.0
|
|
Probability of Relapse-free Survival
Probability of relapse-free survival at 12 months
|
71 percentage probability
Interval 59.0 to 80.0
|
PRIMARY outcome
Timeframe: 1 yearNumber of patients with SAEs which are possibly, probably or definitely drug-related following clinician's assessment or that lead to permanent drug discontinuations during the first year of pentamidine administration
Outcome measures
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearDuring the first year of pentamidine administration for prophylaxis: participants with any drug-related non-serious adverse events (with drug-related defined as possibly, probably or definitely related to primary therapy following physicians assessment) as well as any serious adverse events (drug-related or not)
Outcome measures
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Number of Participants With Adverse Events
Drug-related non-serious adverse events
|
30 Participants
|
|
Number of Participants With Adverse Events
Any serious adverse event
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 monthsNumber of treatment discontinuations and interruptions/missed doses.
Outcome measures
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Number of Treatment Discontinuations and Interruptions
Permanent discontinuation
|
2 number of events
|
|
Number of Treatment Discontinuations and Interruptions
Missed more than 1 dose
|
4 number of events
|
|
Number of Treatment Discontinuations and Interruptions
Treatment interruption
|
0 number of events
|
SECONDARY outcome
Timeframe: 30 monthsThe number of required additional clinical interventions/therapeutic procedures
Outcome measures
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 Participants
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Number of Required Additional Interventions
Additional IV fluid during PM administration
|
10 number of events
|
|
Number of Required Additional Interventions
Prolonged hospital observation
|
2 number of events
|
|
Number of Required Additional Interventions
additional medication during PM infusion
|
2 number of events
|
|
Number of Required Additional Interventions
Additional IV or oral glucose
|
1 number of events
|
Adverse Events
Pentamidine Secondary Prophylaxis (PSP)
Serious events: 33 serious events
Other events: 71 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 participants at risk
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Upper gastro-intestinal haemorrhage
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Disseminated tuberculosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Herpes Zoster
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bacterial Lymphadenitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Meningitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
21.6%
16/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Renal failure
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Blood and lymphatic system disorders
Hypovolemic shock
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Uveitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Appendicitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Cellulitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Giardiasis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Tuberculosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Tuberculosis of central nervous system
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Typhoid fever
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Acute renal failure
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Visceral Leishmaniasis
|
27.0%
20/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
Other adverse events
| Measure |
Pentamidine Secondary Prophylaxis (PSP)
n=74 participants at risk
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.2%
9/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
13/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Dyspepsia
|
14.9%
11/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Gastritis
|
12.2%
9/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Peptic ulcer
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Cataract
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Allergic conjunctivitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Eye allergy
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Eye degenerative disorder
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Iridocyclitis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Night blindness
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Ocular hyperaemia
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Refraction disorder
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Eye disorders
Uveitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Abdominal distention
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Upper abdominal pain
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Anal fistula
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Haemorrhagic diarrhoea
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Proctitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Toothache
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhagues
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Application site hypersensitivity
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Asthenia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Chest pain
|
13.5%
10/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Chills
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Injection site hypersensitivity
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Local swelling
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Pain
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
General disorders
Pyrexia
|
13.5%
10/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Immune system disorders
Hypersensitivity
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Abscess limb
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Abscess neck
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Acarodermatitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Acute tonsillitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Amoebiasis
|
8.1%
6/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Amoebic dysentery
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Anal abscess
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Appendicitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Ascariasis
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Atypical pneumonia
|
9.5%
7/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Body tinea
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bronchitis
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bronchopneumonia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Carbuncle
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Cellulitis
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Cerebral toxoplasmosis
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Cestode infection
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Chlamydial infection
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Cystitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Disseminated tuberculosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Dysentery
|
12.2%
9/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Eye infection
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bacterial eye infection
|
9.5%
7/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Folliculitis
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Fungal skin infection
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Furuncle
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Gastroenteritis
|
21.6%
16/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Giardiasis
|
18.9%
14/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Helminthic infection
|
9.5%
7/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Viral hepatitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Herpes Zoster
|
8.1%
6/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Hookworm infection
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Hordeolum
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Impetigo
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Influenza
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Intertrigo candida
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Isopsoriasis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Lower respiratory tract infection
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Lymph node tuberculosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bacterial lymphadenitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Malaria
|
25.7%
19/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Meningitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Nasopharingitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Oesophageal candidiasis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Oral candidiasis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Oral herpes
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Otitis media
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Acute otitis media
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Periorbital cellulitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Bacterial peritonitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Plasmodium falciparum infection
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Plasmodium vivax infection
|
10.8%
8/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Pneumonia
|
43.2%
32/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Pulpitis dental
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Pyomyositis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Sepsis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Sinusitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Skin infection
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Strongyloidiasis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Syphilis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Taeniasis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Tonsillitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Tuberculosis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Tuberculosis of central nervous system
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Typhoid fever
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
7/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Urinary tract infection
|
13.5%
10/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Visceral leishmaniasis
|
28.4%
21/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Infections and infestations
Wound infection
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Accident at work
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Animal bite
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Chest injury
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Laceration
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Injury, poisoning and procedural complications
Wound
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Blood albumin decreased
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Blood alkaline phosphatase increased
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Blood creatinine increased
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Creatinine renal clearance decreased
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Platelet count decreased
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Investigations
Weight decreased
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.9%
11/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Tetany
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Arthralgia
|
18.9%
14/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Back pain
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Myalgia
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Metabolism and nutrition disorders
Pain in extremity
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Convulsion
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Dizziness
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Headache
|
10.8%
8/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Migraine
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Myelopathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Neuralgia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Peripheral neuropathy
|
10.8%
8/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Polyneuropathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Nervous system disorders
Post herpetic neuropathy
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Psychiatric disorders
Somatoform disorder
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Renal failure
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Acute renal failure
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Renal and urinary disorders
Urethral discharge
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Reproductive system and breast disorders
Genital ulceration
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Reproductive system and breast disorders
Gynaecomastia
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Reproductive system and breast disorders
Scrotal swelling
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Reproductive system and breast disorders
Testicular swelling
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.6%
16/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
4.1%
3/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
5/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
4/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Vascular disorders
Hypotension
|
17.6%
13/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Vascular disorders
Hypovolaemic shock
|
2.7%
2/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
|
Vascular disorders
Shock
|
1.4%
1/74 • Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
|
Additional Information
Johan Van Griensven
Institute of Tropical Medicine Antwerp
Phone: +32(0)32476426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place