Trial Outcomes & Findings for Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3 (NCT NCT04880395)
NCT ID: NCT04880395
Last Updated: 2025-07-30
Results Overview
Percentage of patients with viral load \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
265 participants
Primary outcome timeframe
Week 48
Results posted on
2025-07-30
Participant Flow
Recruitment period: May 17th, 2021 - May 04th, 2023. Sites from Argentina and Brazil.
Eligible participants were non-pregnant, not breastfeeding adults (18 years or older) living with HIV-1, ART naïve, having plasma HIV-1 (pVL) RNA ≥1,000 copies/mL and, CD4 cll counts≤ 200 cells/mm³ at screening. Key exclusión criteria included a positive Hepatitis B coinfection, pre-existing major viral resistance mutations to DTG, 3TC, or TDF, active opportunistic infections, liver or kidney disease.
Participant milestones
| Measure |
Experimental : Dolutegravir Plus Lamivudine
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
77
|
|
Overall Study
COMPLETED
|
140
|
71
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Baseline characteristics by cohort
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=153 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
34 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
26 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
52 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other (Hispanic- Latino/Mixed)
|
67 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
CD4 cell count
|
109 cell/mL
n=5 Participants
|
128 cell/mL
n=7 Participants
|
116 cell/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses
Percentage of patients with viral load \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3.
|
125 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses
Percentage of patients treated with DTG+3TC and DTG+TDF/XTC with HIV-1 levels of less than 50 copies/mL at week 24
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Antiviral Activity of DTG+3TC and DTG+TDF/XTC (TDF/FTC or TDF/3TC) at Week 24
|
110 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: week 48Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses
Percentage of patients who discontinue treatment due to adverse events or death
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Safety and Tolerability of DTG+3TC and DTG+TDF/XTC Over Time
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses
Percentage of patients with baseline viral load \>100,000 c/mL that reach HIV-1 levels of less than 50 copies/mL at week 48
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=94 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=47 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Antiviral Activity of DTG+3TC and DTG+TDF/XTC at Week 48 in Patients With Baseline Viral Load >100,000 c/mL
|
76 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses
Changes in lymphocytes CD4 cells count per mL
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Changes in Lymphocytes Subsets Between Baseline and 48 Weeks
|
200 cell/mL
Interval 127.0 to 316.0
|
177 cell/mL
Interval 128.0 to 267.0
|
SECONDARY outcome
Timeframe: week 48Number and type of resistance mutations in case of virologic failure (defined as a confirmed viral above 200 copies/mL on or after week 24 or confirmed viral rebound at any timepoint)
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=18 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=9 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Development of HIV-1 Resistance in Patients With Virologic Failure or Viral Rebound Whilst Being Treated With DTG+3TC or DTG+TDF/XTC
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 48Population: One participant randomized to experimental arm was withdrawn before receiving any dose and therefore excluded from all analyses.
Evaluation of disease progression incidence (HIV-associated conditions, AIDS and death) with DTG+3TC and DTG + TDF/XTC treatment over time
Outcome measures
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 Participants
DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 Participants
Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
|
|---|---|---|
|
Incidence of IRIS or Disease Progression (HIV Associated Conditions, AIDS and Death).
|
9 Participants
|
6 Participants
|
Adverse Events
Experimental : Dolutegravir Plus Lamivudine
Serious events: 15 serious events
Other events: 37 other events
Deaths: 4 deaths
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
Serious events: 9 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 participants at risk
Dolutegravir 50 mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 participants at risk
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD, OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
Data related to the use of TDF/3TC or TDF/FTC was not discriminated. Both options used were considered as a single treatment arm: TDF/XTC plus dolutegravir.
|
|---|---|---|
|
Infections and infestations
Tuberculosis meningoencephalitis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
IRIS in tuberculous meningitis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Blood and lymphatic system disorders
Possible lymphoma
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pneumonia
|
0.00%
0/152 • 52 weeks
|
2.6%
2/77 • Number of events 2 • 52 weeks
|
|
Eye disorders
Bilateral herpetic retinitis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Immune system disorders
Burkitt's lymphoma (non-Hodgkin's lymphoma)
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Cardiac disorders
Probable aortic aneurysm rupture
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder with metástasis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Renal and urinary disorders
Ureteral rupture
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
Disseminated TB with meningeal involvement
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Infection
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Eye disorders
Cytomegalovirus chorioretinitis and vitritis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
General disorders
Car accident
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Blood and lymphatic system disorders
Hospitalization for investigation of pancytopenia
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Immune system disorders
Investigation of fever, disorientation and weight loss
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Esophagus substenosis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Renal tubular acidosis + Bronchopneumonia
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia febrile
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Probable pulmonary tuberculosis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Neurotoxoplasmosis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Cryptosporidiosis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
Other adverse events
| Measure |
Experimental : Dolutegravir Plus Lamivudine
n=152 participants at risk
Dolutegravir 50 mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
|
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine)
n=77 participants at risk
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD, OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
Data related to the use of TDF/3TC or TDF/FTC was not discriminated. Both options used were considered as a single treatment arm: TDF/XTC plus dolutegravir.
|
|---|---|---|
|
General disorders
Insomnia/Nightmares
|
3.9%
6/152 • Number of events 6 • 52 weeks
|
3.9%
3/77 • Number of events 3 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Itching/Rash/Prurigo
|
2.0%
3/152 • Number of events 3 • 52 weeks
|
5.2%
4/77 • Number of events 4 • 52 weeks
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
1.3%
2/152 • Number of events 3 • 52 weeks
|
3.9%
3/77 • Number of events 4 • 52 weeks
|
|
Nervous system disorders
Headache
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
3.9%
3/77 • Number of events 3 • 52 weeks
|
|
Psychiatric disorders
Depressive symptoms/Depression
|
1.3%
2/152 • Number of events 2 • 52 weeks
|
2.6%
2/77 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain/Epigastralgia/Dyspepsia
|
1.3%
2/152 • Number of events 2 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
3/152 • Number of events 3 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/152 • 52 weeks
|
3.9%
3/77 • Number of events 3 • 52 weeks
|
|
Metabolism and nutrition disorders
Weight gain
|
2.0%
3/152 • Number of events 3 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Hepatobiliary disorders
Elevated transaminases
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Endocrine disorders
Hiperglucemia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Metabolism and nutrition disorders
Amylase elevation
|
1.3%
2/152 • Number of events 2 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Renal and urinary disorders
Creatinine increase
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Malassezia folliculitis
|
1.3%
2/152 • Number of events 2 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Endocrine disorders
Hypercholesterolemia/ Dyslipidemia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Blood and lymphatic system disorders
Plateletopenia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Aphthous stomatitis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
IRIS in Tuberculous meningitis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
Disseminated Tuberculosis with meningeal involvement
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Impetigo
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pharmacodermia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Eye disorders
Cytomegalovirus retinitis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Blood and lymphatic system disorders
Bilateral cervical lymphadenopathy
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
General disorders
Fever
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia febrile
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
Hypoesthesia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Gastrointestinal disorders
Fever, diarrhea, abdominal pain
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Generalized Rash
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Hepatobiliary disorders
Lipid increase
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Epigastric pain
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Eye disorders
Viral conjunctivitis
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Ulcer in the left ear
|
0.00%
0/152 • 52 weeks
|
1.3%
1/77 • Number of events 1 • 52 weeks
|
|
Hepatobiliary disorders
Glutamic Oxaloacetic Transaminase increase
|
0.66%
1/152 • Number of events 1 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
Additional Information
Dr. María Inés Figueroa
Fundación Huésped - Buenos Aires
Phone: +54 11 2120-9999
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any documents, reports or data received or generated by PIs under the Agreement, including in particular those containing or reflecting specific information or the Study's results or data, may not be used, disclosed, communicated or published by PIs, whether for its own benefit or that of third parties, free of charge or against payment, in any country, without first obtaining the prior written permission of Fundación Huésped (Sponsor) in each instance.
- Publication restrictions are in place
Restriction type: OTHER