Trial Outcomes & Findings for Sodium Stibogluconate Treatment of Leishmaniasis (NCT NCT00662012)

NCT ID: NCT00662012

Last Updated: 2021-02-12

Results Overview

The primary safety endpoint is the frequency of complications of therapy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 414 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2021-02-12

Participant Flow

Recruitment commenced on 11May2002 with follow-up periods ranging from 12 to 24 months after completion of treatment. Treatment was received at Walter Reed Army Medical Center, Washington, DC, USA.

Participant milestones

Measure	SSG 20 mg/kg All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Overall Study STARTED	414
Overall Study COMPLETED	327
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Measure	SSG 20 mg/kg All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Overall Study Lost to Follow-up	85
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Sodium Stibogluconate Treatment of Leishmaniasis

Baseline characteristics by cohort

Measure	SSG 20 mg/kg n=414 Participants All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Age, Continuous	28.1 years STANDARD_DEVIATION 7.96 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	405 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	62 Participants n=5 Participants
Race (NIH/OMB) White	295 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	50 Participants n=5 Participants
Region of Enrollment United States	414 participants n=5 Participants
Lesion data - Duration since onset	111.6 Days STANDARD_DEVIATION 47.62 • n=5 Participants
Lesion data - Number of lesions	5.0 Lesions STANDARD_DEVIATION 5.04 • n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Analysis was per protocol

The primary safety endpoint is the frequency of complications of therapy

Outcome measures

Measure

SSG 20 mg/kg n=414 Participants All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

The Primary Safety Endpoint - Frequency of Complications of Therapy

414 participants

SECONDARY outcome

Timeframe: 5 years

Population: Analysis per protocol

Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.

Outcome measures

Measure

SSG 20 mg/kg n=414 Participants All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .

414 participants

Adverse Events

SSG 20 mg/kg

Serious events: 17 serious events

Other events: 414 other events

Deaths: 0 deaths

Serious adverse events

Measure	SSG 20 mg/kg n=414 participants at risk All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Gastrointestinal disorders Abdominal Pain	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Nausea	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Retching	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Chills	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Pyrexia	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Hepatobiliary disorders Cholecystitis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Hepatobiliary disorders Cholelithiasis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Immune system disorders Drug Hypersensitivity	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Erysipelas	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Immune system disorders Meningitis Aseptic	0.72% 3/414 • Number of events 3 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Postoperative Wound Infection	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Multiple Fractures	0.48% 2/414 • Number of events 2 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Metabolism and nutrition disorders Diabetes Mellitus	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Back Pain	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Neuropathy	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Partial Seizures	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Renal and urinary disorders Calculus Ureteric	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Renal and urinary disorders Nephrolithiasis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Angioneurotic Oedema	0.48% 2/414 • Number of events 2 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Swelling Face	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Urticaria	0.48% 2/414 • Number of events 2 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Lymphacele	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Coronary Artery Disease	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Hepatobiliary disorders Gall Bladder Disorder	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Appendicitis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Cutaneous Leishmaniasis	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Head Injury	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Heat Exhaustion	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Injury	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Road Accident	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Injury, poisoning and procedural complications Wound	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Biopsy Liver	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.48% 2/414 • Number of events 2 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Psychiatric disorders Post-Traumatic Stress Disorder	0.48% 2/414 • Number of events 2 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Renal and urinary disorders Renal Failure Acute	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Skin Lesion	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Surgical and medical procedures Cholecystectomy	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Aneurysm Ruptured	0.24% 1/414 • Number of events 1 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.

Other adverse events

Measure	SSG 20 mg/kg n=414 participants at risk All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG. Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Blood and lymphatic system disorders Anemia	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Blood and lymphatic system disorders Leukopenia	5.1% 21/414 • Number of events 21 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Blood and lymphatic system disorders Lymphadenopathy	14.3% 59/414 • Number of events 59 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Blood and lymphatic system disorders Thrombocytopenia	2.4% 10/414 • Number of events 10 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Bundle Branch Block Left	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Blood and lymphatic system disorders Bundle Branch Block Right	5.3% 22/414 • Number of events 22 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Conduction Disorder	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Dilatation Atrial	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Palpitations	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Sinus Tachycardia	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Supraventricular Extrasystoles	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Tachycardia	13.3% 55/414 • Number of events 55 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Ventricular Extrasystoles	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Cardiac disorders Ventricular Hypertrophy	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Ear and labyrinth disorders Ear Pain	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Discomfort	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Distension	3.6% 15/414 • Number of events 15 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Pain	28.5% 118/414 • Number of events 118 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Pain Lower	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Pain Upper	8.0% 33/414 • Number of events 33 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Abdominal Tenderness	4.8% 20/414 • Number of events 20 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Constipation	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Diarrhea	14.3% 59/414 • Number of events 59 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Dyspepsia	4.3% 18/414 • Number of events 18 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Flatulence	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Gastritis	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Gastroesophageal Reflux Disease	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Nausea	32.6% 135/414 • Number of events 135 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Pancreatitis	36.5% 151/414 • Number of events 151 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Stomach Discomfort	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Gastrointestinal disorders Vomiting	7.5% 31/414 • Number of events 31 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Asthenia	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Chest Discomfort	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Chest Pain	5.1% 21/414 • Number of events 21 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Chills	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Early Satiety	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Fatigue	70.5% 292/414 • Number of events 292 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Feeling Hot	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Infusion Related Reaction	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Infusion Site Reaction	5.6% 23/414 • Number of events 23 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Oedema Peripheral	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Pain	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Pyrexia	12.3% 51/414 • Number of events 51 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
General disorders Thirst	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Hepatobiliary disorders Hepatitis	10.9% 45/414 • Number of events 45 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Cellulitis	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Folliculitis	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Herpes Simplex	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Herpes Zoster	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Pharyngitis	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Rhinitis	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Sinusitis	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Skin Infection	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Upper Respiratory Tract Infection	17.9% 74/414 • Number of events 74 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Infections and infestations Wound Infection	2.7% 11/414 • Number of events 11 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Alanine Aminotransferase Increased	59.2% 245/414 • Number of events 245 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Anion Gap Decreased	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Aspartate Aminotransferase Increase	48.8% 202/414 • Number of events 202 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Albumin Decreased	12.8% 53/414 • Number of events 53 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Alkaline Phosphatase Increased	4.6% 19/414 • Number of events 19 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Amylase Increased	65.9% 273/414 • Number of events 273 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Billirubin Increased	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Calcium Increased	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Chloride Increased	4.6% 19/414 • Number of events 19 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Glucose Decreased	6.0% 25/414 • Number of events 25 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Glucose Increased	7.0% 29/414 • Number of events 29 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Potassium Decreased	5.1% 21/414 • Number of events 21 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Potassium Increased	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Pressure Increased	4.6% 19/414 • Number of events 19 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Sodium Increased	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Blood Urea Increased	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Body Temperature Increased	2.4% 10/414 • Number of events 10 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram P Wave Abnormal	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram QRS Complex Abnormal	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram ST Segment Abnormal	6.8% 28/414 • Number of events 28 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram ST Segment Elevation	2.7% 11/414 • Number of events 11 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram T Wave Abnormal	20.0% 83/414 • Number of events 83 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram T Wave Inversion	3.1% 13/414 • Number of events 13 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrocardiogram Abnormal	5.3% 22/414 • Number of events 22 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Electrodardiogram Repolarisation Abnormality	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Eosinophil Count Increased	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Eosinophil Percentage Increased	7.7% 32/414 • Number of events 32 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Haematocrit Decreased	19.1% 79/414 • Number of events 79 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Haemoglobin Decreased	5.1% 21/414 • Number of events 21 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Heart Rate Increased	4.8% 20/414 • Number of events 20 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Lipase Increased	80.0% 331/414 • Number of events 331 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Lymphocyte Count Decreased	4.1% 17/414 • Number of events 17 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Lymphocyte Percentage Decreased	15.7% 65/414 • Number of events 65 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Lymphocyte Percentage Increased	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Monocyte Count Increased	6.0% 25/414 • Number of events 25 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Monocyte Percentage Increased	18.4% 76/414 • Number of events 76 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Neutrophil Count Decreased	2.7% 11/414 • Number of events 11 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Neutrophil Count Increased	4.1% 17/414 • Number of events 17 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Neutrophil Percentage Decreased	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Neutrophil Percentage Increased	5.3% 22/414 • Number of events 22 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Pancreatic Enzymes Increased	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Platelet Count Decreased	21.3% 88/414 • Number of events 88 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Protein Total Decreased	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations QRS Axis Abnormal	7.5% 31/414 • Number of events 31 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Red Blood Cell Count Decreased	3.9% 16/414 • Number of events 16 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Transaminases Increased	2.4% 10/414 • Number of events 10 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Tuberculin Test Positive	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations Urine Antimony Increased	2.7% 11/414 • Number of events 11 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations White Blood Cell Count Decreased	29.0% 120/414 • Number of events 120 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Investigations White Blood Cell Count Increased	5.3% 22/414 • Number of events 22 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Metabolism and nutrition disorders Anorxia	13.0% 54/414 • Number of events 54 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Metabolism and nutrition disorders Decreased Appetite	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Arthralgia	69.1% 286/414 • Number of events 286 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Back Pain	10.6% 44/414 • Number of events 44 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Flank Pain	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Groin Pain	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Joint Stiffness	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	4.3% 18/414 • Number of events 18 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Myalgia	61.1% 253/414 • Number of events 253 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Neck Pain	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Pain in Extremity	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Pain in Jaw	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Musculoskeletal and connective tissue disorders Shoulder Pain	3.1% 13/414 • Number of events 13 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Dizziness	7.2% 30/414 • Number of events 30 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Dysgeusia	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Headache	51.2% 212/414 • Number of events 212 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Hypoaesthesia	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Migraine	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Paraesthesia	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Nervous system disorders Somnolence	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Psychiatric disorders Depression	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Psychiatric disorders Insomnia	10.1% 42/414 • Number of events 42 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Psychiatric disorders Post-traumatic Stress Disorder	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Psychiatric disorders Sleep Disorder	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 20/414 • Number of events 20 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 9/414 • Number of events 9 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.9% 12/414 • Number of events 12 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	4.6% 19/414 • Number of events 19 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Acne	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 18/414 • Number of events 18 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Dry Skin	1.4% 6/414 • Number of events 6 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Night Sweats	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Pruritus	4.1% 17/414 • Number of events 17 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Rash	16.2% 67/414 • Number of events 67 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Rash Papular	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Rash Pruritic	1.2% 5/414 • Number of events 5 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Skin Lesion	8.5% 35/414 • Number of events 35 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Skin and subcutaneous tissue disorders Urticaria	2.4% 10/414 • Number of events 10 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Flushing	1.7% 7/414 • Number of events 7 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Hot Flush	0.97% 4/414 • Number of events 4 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Hypertension	5.6% 23/414 • Number of events 23 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.
Vascular disorders Phlebitis	1.9% 8/414 • Number of events 8 • The study included a screening/baseline period, a 10-20 or 28-day treatment period, and a 12-24 month follow-up period. 10 days for cutaneous leishmaniasis due to L. major, 20 days for cutaneous leishmaniasis due to other species and for some more severe or less responsive L. major infections, 28 days for mucocutaneious, viscerotripic, or visceral leishmaniasis.

Additional Information

Naomi Aronson, MD

Uniformed Services University of Health Sciences (USUHS)

Phone: (301) 295-3621

Email: naomi.e.aronson.civ@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place