scholarly journals Features of the course of hemorrhagic fever with renal syndrome in HIV-infected patients

2021 ◽  
Vol 11 (5) ◽  
pp. 951-957
Author(s):  
K. M. Manakhov ◽  
E. V. Povysheva ◽  
A. R. Gilyazova ◽  
D. S. Sarksyan
Keyword(s):  
Hiv Infection ◽  
Rating Scale ◽  
Hemorrhagic Fever ◽  
Developed Countries ◽  
Kidney Damage ◽  
Renal Pathology ◽  
Lumbar Region ◽  
Mild Disease ◽  
Group 2 ◽  
Group 1

Human immunodeficiency virus (HIV) is a significant medical and social problem for many developed countries. HIV infection is featured with developing chronic kidney pathology as well as acute renal damage. In some regions, hemorrhagic fever with renal syndrome (HFRS) can contribute somehow to developing renal pathology in HIVinfected subjects. The aim of the study was to identify clinical and laboratory features of HFRS course during HIV infection. A retrospective study was conducted by forming two groups: group 1 consisted of 9 patients suffered from HFRS together with verified HIV infection, group 2 — 53 patients with HFRS but lacking any clinical and epidemiological indications supporting HIV infection. Subjects in both groups were age- and sex-matched. The average age of the patients in group 1 and group 2 was 34 and 31 years, respectively. For statistical analysis, the licensed SPSS 22.0 software was used. A significance level p for statistical criteria was set equal to 0.05. In general, HFRS course in all patients was accompanied by characteristic signs: intoxication syndrome, impaired vision, hemorrhagic rash, pain in the lumbar region, decreased diuresis, thrombocytopenia, proteinuria, polymorphic urinary syndrome and azotemia. HFRS patients with concomitant HIV infection often complain of dry mouth, bloating, visible shortness of breath. Laboratory changes describe more severe kidney damage. A direct strong correlation was shown between leukocyte count and level of blood urea in patients with concomitant HIV infection (r = 0.798; p = 0.01). The combination of HFRS and HIV was accompanied by a milder HFRS course — rate of mild disease was almost 6-fold higher among patients of this group. In this case, no cases of severe hemorrhagic fever with renal syndrome combined with HIV were noted. Our study allowed to obtain unambiguous data. Predisposition of HIV-infected patients to renal pathology may be a determining factor in kidney damage upon emerging HFRS: more prominent rise in creatinine and urea level. Moreover, according to rating scale for assessing HFRS severity, it formally turned out that during concomitant HIV infection patients more often fit to a mild disease severity, even in the presence of more pronounced renal manifestations. The occurrence of acute renal pathology in HIV-infected patients is a life-threatening condition, a factor of deterioration of chronic renal pathology and a predictor of death. Consequently, this patient population requires thorough monitoring both at inpatient and outpatient stages.

scholarly journals The use of an antagonist 5-HT2a/c for depression and motor function in Parkinson' disease

2009 ◽  
Vol 67 (2b) ◽  
pp. 407-412 ◽  
Author(s):  
Antonio Luiz dos Santos Werneck ◽  
Ana Lucia Rosso ◽  
Maurice Borges Vincent
Keyword(s):  
Parkinson Disease ◽  
Motor Function ◽  
Rating Scale ◽  
Statistical Significance ◽  
Psychotic Symptoms ◽  
Initial Moment ◽  
The Mean ◽  
Group 2 ◽  
To Receive ◽  
Group 1

OBJECTIVE: To test the ability of a 5HT2a/c (trazodone) antagonist, to improve depression and motor function in Parkinson' disease (PD). METHOD: Twenty PD patients with and without depression were randomly assigned to receive trazodone (group 1) or not (group 2). They were evaluated through UPDRS and Hamilton Depression Rating Scale (HAM-D). RESULTS: For the UPDRS the mean score of group 2 was 33.1 ± 19.7 and 37.1 ± 18.0 at the end. For the group 1, the corresponding scores were 31.4 ± 11.3 and 25.9 ± 13.7. The variations in the Mann-Whitney test were 0.734 at the initial moment and 0.208 at the final moment. The variation in the comparison of the initial moment with the final moment was 0.005 providing statistical significance. For the HAM-D, the mean score went up 4 points in group 2, contrary to a 5.5 points decrease in group 1. CONCLUSION: Data analysis shows that this agent significantly improves depression, but the motor function improved only in the depressed patients. Because of the known anti-dopaminergic property of the 5-HT2c receptors, a possible approach for depression in PD could be the use of 5-HT2c antagonists, similarly to the use of atypical neuroleptics in case of psychotic symptoms.

scholarly journals Retinal microvascular abnormalities in patients after COVID-19 depending on disease severity

2020 ◽  
pp. bjophthalmol-2020-317953
Author(s):  
Miguel Ángel Zapata ◽  
Sandra Banderas García ◽  
Adrián Sánchez ◽  
Anna Falcó ◽  
Susana Otero-Romero ◽  
...  
Keyword(s):  
Respiratory Distress ◽  
Severe Disease ◽  
Control Group ◽  
Vascular Density ◽  
Mild Disease ◽  
Global Pandemic ◽  
Group 3 ◽  
Group 2 ◽  
Group Control Group ◽  
Group 1

BackgroundGlobal pandemic SARS-CoV-2 causes a prothrombotic state without fully elucidated effects. This study aims to analyse and quantify the possible retinal microvascular abnormalities.Materials and methodsCase–control study. Patients between 18 and 55 years old with PCR-confirmed SARS-CoV-2 infection within the last 3 months were included. Risk stratification: group 1—mild disease (asymptomatic/paucisymptomatic); group 2—moderate disease (required hospital admission with no acute respiratory distress) and group 3—severe disease (subjects who developed an acute respiratory distress were admitted in the intensive care unit and presented interleukin 6 values above 40 pg/mL). Age-matched volunteers with negative serology tests were enrolled to control group. A colour photograph, an optical coherence tomography (OCT) and an angiography using OCT centred on the fovea were performed.ResultsControl group included 27 subjects: group 1 included 24 patients, group 2 consisted of 24 patients and 21 participants were recruited for group 3. There were no funduscopic lesions, neither in the colour images nor in the structural OCT. Fovea-centred vascular density (VD) was reduced in group 2 and group 3 compared with group 1 and control group (control group vs group 2; 16.92 vs 13.37; p=0.009) (control group vs group 3; 16.92 vs .13.63; p=0.026) (group 1 vs group 2; 17.16 vs 13.37; p=0.006) (group 1 vs group 3; 17.16 vs 13.63 p=0.017).ConclusionPatients with moderate and severe SARS-CoV-2 pneumonia had decreased central retinal VD as compared with that of asymptomatic/paucisymptomatic cases or control subjects.

scholarly journals A Comparative Study of the Effect of Sutureless Versus Multiple Sutures Technique on Complications following Third Molar Surgery in Nepalese Subpopulation

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Arun Kr. Mahat ◽  
Ram Yadav ◽  
Anjani Kr. Yadav ◽  
Pradeep Acharya ◽  
Ashok Dongol ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Third Molar ◽  
Third Molar Surgery ◽  
Surgical Removal ◽  
Sutureless Technique ◽  
Lateral Canthus ◽  
Duration Of Surgery ◽  
Group 2 ◽  
Group 1

Objective. To compare the effect of sutureless versus multiple sutures technique on postoperative variables such as pain, swelling, and trismus after surgical removal of the third molar in Nepalese subpopulation. Materials and Methods. Forty-eight patients were equally grouped into multiple sutures (group 1) and sutureless (group 2) groups using a computer-generated random table. The same operator performed all the surgical procedures. Postoperative variables such as pain, swelling, and trismus were measured by a single concealed observer using a 10 cm Numerical Rating Scale (NRS), flexible plastic measuring tape, and vernier caliper preoperatively and on 1st, 2nd, and 7th postoperative days. Results. This study showed significantly more swelling measured from the gonion to lateral canthus in group 1 than in group 2 on all postoperative periods (P<0.05). The mean NRS score was significantly higher in group 1 on the 1st postoperative day (P=0.01). Though mean duration of surgery, swelling as measured from tragus to commissure, trismus, NRS score except on the 1st postoperative day, total number of analgesics consumed, and complications were noted more in the multiple sutures group, the difference was not statistically significant. Conclusion. Our results support the use of sutureless technique after third molar surgery to minimize postoperative morbidity and the overall operative time and reduce the cost within the Nepalese subpopulation.

Hodgkin Lymphoma: 20 Years Experience From a Single Brazilian Institution

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3153-3153
Author(s):  
Camila C.G. Linardi ◽  
Luis Fernando Pracchia ◽  
Rodrigo Dolphini Velasques ◽  
Claudia Bitti Barroso ◽  
Valeria Buccheri
Keyword(s):  
Prognostic Factors ◽  
Hodgkin Lymphoma ◽  
Developed Countries ◽  
Stage I ◽  
Advanced Stage ◽  
Bulky Disease ◽  
Free Survival ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Abstract 3153 Hodgkin Lymphoma (HL) is characterized by high cure rates. Approximately 90% early stage and 60–70% advanced stage patients have long term disease free survival. In Brazil it is observed that about 60% of patients present with advanced stage, while in developed countries about 40% belong to this group. The aim of this retrospective study was to analyze data of patients with HL from the Oncohematology Unit of University of São Paulo- Medical School and evaluate the event free survival (EFS) and the overall survival (OS) according to clinical stage. We included all consecutive patients diagnosed with HL between January 1991 and June 2010. The collection of data from medical records was done and the following variables at diagnosis were evaluated: age and sex, staging according to Cotswolds modified Ann-Arbor criteria (CS), histological subtype, presence of B symptoms and bulky disease, International Prognostic Index (IPI) according to International Prognostic Factors Project on Advanced Hodgkin's Disease, laboratorial data, and the protocol used in first line therapy. The complete remission (CR) rate, EFS and OS were analyzed in all patients. The survival analysis was estimated by the Kaplan-Meier method and the survival curves were compared by the log-rank test. Differences in CR rates among staging groups were compared using the chi squared test. Overall, 564 HL patients were identified; thirteen did not have adequate information about clinical staging and were excluded from the analysis. The median age, at diagnosis, of the remaining 551 patients was 28 (12–83) and 54.3% were male. Histological subtypes lymphocyte rich classical HL, nodular sclerosis, mixed cellularity and lymphocyte depletion were found in 3.6%, 51.4%, 24.2% and 5.6% cases, respectively, and 11.8% patients were diagnosed as HL classic not classifiable otherwise. Nodular lymphocyte predominance was observed in 3.3% cases. Stage I, II, III and IV were found in 42 (7.6%), 208 (37.7%), 145 (26.3%) e 156 (28.3%) patients, respectively. B symptoms and bulky disease were present in 65.5%and 58.8% patients, respectively. After staging the patients were divided in three groups: group 1 -CS I/II, without B symptoms nor bulky disease= 62 (11.25%) patients, group 2 -CS I/ II, with B symptoms and/or bulky disease=188 (34.12%) patients and group 3- CS III/ IV= 301 (54.62%) patients. IPI high risk score was recognized in 63.9% patients of group 3. Only 1.5% of patients were treated with exclusive radiotherapy. Of the patients that were treated with chemotherapy, 4.9% were treated with MOPP, 23.1% with MOPPABV, 70.5% with ABVD and 1.5% with other types of chemotherapy. The median follow-up of the entire cohort was 59.6 months (0–258.8 months) and 88.3% (CI 95%: 85.2%-91.1%) were in CR at the end of treatment (CS I: 100%, CS II: 90.6% CS III: 84.6% and CS IV: 85.3%; p=0.03) (group 1: 98.2%, group 2: 90.2% and group 3: 84.9%; p=0.012). The 5-year EFS rate was 69.2% (CS I: 84.8%; CS II: 77.8%; CS III: 64.5%, CS IV: 56%; p=0.0008) (group 1: 88%, group 2: 76% and group 3: 60.3%; p=0.0002) (Figures 1 and 2). The 5-year OS rate was 86.44% (CS I: 90.3%, CS II: 94.6%, CS III: 87.6%, CS IV: 71.4%; p<0.0001) (group 1: 98.3%, group 2: 92.6% and group 3: 79, 6%; p=0.0003).Figure 1Figure 1. Figure 2Figure 2. We found that there were more advanced stage patients (stage III/IV) in comparison to developed countries, however, patients classified as stage I/II without poor prognostic factors, like B symptoms and/or bulky disease, showed high rates of CR, EFS and OS. These data suggest that there is a need to enhance early diagnosis in Brazilian patients, in order to detect less advanced stage patients due to late diagnosis. Disclosures: No relevant conflicts of interest to declare.

Perceptual Anchors and the Dispersion of Nasality Ratings

2017 ◽  
Vol 54 (4) ◽  
pp. 423-430 ◽  
Author(s):  
Kristine E. Galek ◽  
Thomas Watterson
Keyword(s):  
Outcome Measures ◽  
Rating Scale ◽  
Speech Disorders ◽  
Absolute Judgment ◽  
Q Value ◽  
Point Scale ◽  
Group 4 ◽  
Group 5 ◽  
Group 2 ◽  
Group 1

Objective This investigation studied the effects of perceptual anchors on the dispersion and reliability of listener ratings of nasality. Design Listeners (N = 129) were assigned to one of six listening groups. Each group rated nasality independently for 100 speech samples on a seven-point scale that ranged from 1 = normal nasality to 7 = severe hypernasality. The anchors used were examples of a 1, 3, 4, 5, and/or 7 on the rating scale. These anchors were played selectively to group 2 (4), group 3 (1 and 7), group 4 (3 and 5), group 5 (1, 4, 7), and group 6 (7). Group 1 had no anchor. Participants Of the speakers, 95 were children followed by a craniofacial team and five were children without histories of speech disorders. Main Outcome Measures The outcome measures were 12,900 ratings of nasality on a seven-point scale. Results Q values showed that group 5, which was the only group to receive three anchors, had the lowest, or best, Q value (0.78), and group 1 (no anchor) had the highest, or worst, Q value (0.99). Across groups, the most reliable ratings were those at scale values 1 (Q = 0.46) and 7 (Q = 0.56). The least reliable ratings were at scale values 3 (Q = 1.01), 4 (Q = 1.03), and 5 (Q = 1.06). Conclusions Nasality rating reliability/dispersion was influenced by the presence and location of anchor stimuli. Consistent with absolute judgment theory, nasality ratings showed a strong end effect.

scholarly journals Psychiatric morbidity in newly diagnosed carcinoma cervix and its comparison with benign condition

2017 ◽  
Vol 6 (11) ◽  
pp. 4990
Author(s):  
Rajnish Raj ◽  
Nisha Bhagat
Keyword(s):  
Social Impact ◽  
Rating Scale ◽  
Psychiatric Morbidity ◽  
Depression Scale ◽  
Newly Diagnosed ◽  
Carcinoma Cervix ◽  
Benign Condition ◽  
Group 2 ◽  
Hamilton Rating Scale ◽  
Group 1

Background: To study the psychiatric morbidity among newly diagnosed carcinoma cervix and its comparison with benign gynaecological diseases of cervix. Cervical cancer is the second most common cancer in the world and ranked first in India. It is mainly caused by sexually transmitted infection (STI) of human papilloma virus (HPV).Methods: It was an open labeled, cross-sectional and extended phase study that screened 158 patients in the age group of 18-70 years who fulfilled both inclusion and exclusion criteria and screened positive on liquid based cytology (LBC), as per guidelines of Bathesda system in Government Medical College, Patiala. 13 patients dropped out of study and finally 145 patients were enrolled. They were further divided after biopsy into two groups as per histopathological examination (HPE) i.e., Group-1, N=47 women HPE positive for cervical intraepithelial neoplasia (CIN) as Cases and Group-2, N=98 HPE negative as Control. and anxiety and severity on Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) and Hospital Anxiety Depression Scale (HADS) was used to screen psychiatric morbidity for depression.Results: Mean age of Group-1 was 38.45±11.22 SD years and Group-2 was 36.67±8.54 SD years. Psychiatric morbidity in Group-1 was 65.95% whereas Group-2 was 21.42%. P value obtained on comparing HADS score of two groups was significant (p <0.050). After active intervention there was a significant reduction in psychiatric morbidity of two groups (72% in Group-1 and 81.3% in Group-2).Conclusions: The study revealed that the breaking of bad news has a significant psycho-social impact on patients suffering from carcinoma cervix than benign group.

scholarly journals Experience on the use of photodynamic therapy in vulvovaginal lichen plane

2020 ◽  
Vol 23 (6) ◽  
pp. 408-413
Author(s):  
Sergey I. Surkichin ◽  
Luidmila S. Holupova
Keyword(s):  
Photodynamic Therapy ◽  
Adverse Events ◽  
Oral Cavity ◽  
Rating Scale ◽  
Secondary Infection ◽  
Treatment Method ◽  
Anogenital Region ◽  
Group 2 ◽  
Corticosteroid Drugs ◽  
Group 1

BACKGROUND: Lichen plane (LP) occurs in 0.5%1% of the population. The exact epidemiology of genital LP is unknown. According to various data, LP occurs in 49% of all cases of vulvar lesions. The LP of the oral cavity and the vulva occurs in 1957% of cases. The clinical forms of LP that occur in the anogenital region in women include the erosive, papulosquamous, and less often hypertrophic forms. No distinct guidelines are available for the treatment of vulvar LP. Except for the use of photodynamic therapy (PDT), no randomized controlled trials have been conducted for the treatment of erosive vulvar LP. The research results have shown that PDT can be effective in lichen plane of the oral cavity. AIM: To evaluate the effectiveness of PDT in women with genital LP compared to topical glucocorticosteroids. MATERIALS AND METODS: The study group included 15 patients with a diagnosis of vulvar LP. The patients were divided into two groups depending on the treatment method. Group 1 patients were treated with PDT. Group 2 patients with topical 0.05% betamethasone cream once daily for 1.5 months. RESULTS: Six months after the last procedure, the regression on the genital LP rating scale was 32% in group 1 patients and 25% in group 2 patients. The severity of pain, according to the visual analog scale, was 29% in group 1 and 22% in group 2. As for adverse events, in group 1, four patients experienced a burning sensation and dryness for 23 days after the procedure, and one patient, after two procedures, had blood discharge, which ceased after 1 day. In group 2, five patients complained of burning and dryness during treatment, two patients had acute candidiasis during treatment, and one patient had bacterial vaginosis. CONCLUSION: The use of PDT can reduce the frequency of use of corticosteroid drugs in the genital area and accordingly reduce the frequency of steroid adverse events, such as atrophy and secondary infection.

scholarly journals Results of treatment with bedaquiline containing regimens of MDR/XDR tuberculosis patients including those with concurrent HIV infection (the experience of Leningrad Region)

2020 ◽  
Vol 98 (9) ◽  
pp. 56-62
Author(s):  
T. I. Danilova ◽  
Yu. V. Korneev ◽  
D. A. Kudlay ◽  
N. Yu. Nikolenko
Keyword(s):  
Hiv Infection ◽  
Group Treatment ◽  
Heart Rhythm ◽  
Mycobacterial Infection ◽  
Leningrad Region ◽  
Results Of Treatment ◽  
Extensive Drug Resistance ◽  
Group 2 ◽  
Icd10 Code ◽  
Group 1

The effectiveness of tuberculosis control is associated with efficacy of treatment of TB patients and above all patients with multiple and extensive drug resistance (MDR/XDR MTB). Patients with TB/HIV co-infection providethe significant impact on the situation.The objective of the study is to assess outcomes of chemotherapy regimens containing bedaquiline in patients with MDR/XDR TB including those with concurrent HIV infection.Subjects and methods. The efficacy and safety of the regimes containing bedaquiline were assessed in the intensive phase of chemotherapy in 80 patients with MDR/XDR TB: Group1 consisted of 46 patients with negative HIV status (ICD10 code A15-A19); Group 2 – 34 HIV positive patients at the advanced stage with manifestations of a mycobacterial infection (ICD10 code B20.0).Results. Treatment outcomes in the groups were as follows: the effective treatment was statistically significantly more frequent in Group 1 versus Group 2 (80.4 and 52.9%, respectively, p = 0.0088). Treatment failure was registered in 3 patients from each group; treatment defaults were statistically significantly more frequent in Group 2 compared to Group 1: in 8/34 versus 2/46 (p = 0.011). 3 patients were transferred out in both Group 1 and Group 2 (3/46 and 3/34, p = 0.69). During treatment, only 1 patient from Group 2 developed an adverse event, most likely associated with the in-take of bedaquiline, a heart rhythm disorder (ventricular arrhythmia) and prolongation of QTcF > 450 ms. 

scholarly journals Could The “Modified 8 D’s of Stroke Care” Improve Sex Disparities in Door-to-Needle Time in Acute Ischemic Stroke?

2022 ◽  
Author(s):  
Meilka Jameie ◽  
Mana Jameie ◽  
Ghasem Farahmand ◽  
Saba Ilkhani ◽  
Hana Magrouni ◽  
...  
Keyword(s):  
Intravenous Thrombolysis ◽  
Stroke Care ◽  
Developed Countries ◽  
Significant Difference ◽  
Sex Disparities ◽  
Group 2 ◽  
Comprehensive Stroke Center ◽  
Stroke Center ◽  
Modified Algorithm ◽  
Group 1

Abstract Background and objectiveDoor-to-needle (DTN) time is an important factor in stroke settings for which studies have reported delays in women, resulting in worse stroke outcomes. We aimed to evaluate whether our modified algorithm could reduce sex disparities, especially in DTN.MethodsThis longitudinal cohort study was conducted between September 1, 2019, and August 31, 2021, at a comprehensive stroke center. Previously we utilized the conventional “D’s of stoke care” for timely management. The “modified 8 D’s of stroke care” was designed by our team in September 2020. Patients were analyzed in two groups: group 1, before, and group 2, after employing the modified algorithm. Sex as the main variable of interest along with other selected covariates were regressed towards the DTN, using univariable and multivariable logistic regressions.ResultsWe enrolled 47 and 56 patients who received intravenous thrombolysis (IVT) in groups 1 and 2, respectively. Although there was a significant difference in DTN≤ 1 hour in group 1 (36% of females vs. 52% of males, p= 0.019), it was not significantly different in group 2 anymore (48% of females vs. 48.4% of males, p= 0.97). Furthermore, regression analysis showed being female was a significant predictor of DTN> 1 hour in group 1 (aOR= 6.65, p= 0.02), while after the modified algorithm gender was not a predictor of delayed DTN anymore.ConclusionAlthough we have a long way to achieve performance measures in developed countries, we seem to have succeeded in reducing gender disparities in DTN using the modified algorithm.

Characterizing fatigue associated with sunitinib (SU) in patients (pts) with metastatic renal cell carcinoma (mRCC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6092-6092
Author(s):  
David Cella ◽  
Mellar P. Davis ◽  
Andrew G. Bushmakin ◽  
Joseph C Cappelleri ◽  
Elizabeth A Hahn ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Rate Of Change ◽  
Initial Increase ◽  
Time Pattern ◽  
Mean Values ◽  
Patient Reported ◽  
Group 2 ◽  
Group 1 ◽  
Cycle Fluctuation

6092 Background: Fatigue is common in cancer pts and associated with use of tyrosine kinase inhibitors (TKIs) such as SU. Limited data exist on the time pattern of fatigue with TKI therapy. Methods: Data from treatment-naïve mRCC pts in SU arms of two clinical trials were analyzed retrospectively. Study 1; 375 pts were randomized to SU 50 mg/d on a 4 weeks-on-2-weeks-off schedule (Schedule 4/2), for up to 30 cycles. Study 2; pts were randomized to SU 50 mg/d Schedule 4/2 (Group 1; n=146) or 37.5 mg/d continuous daily dosing (CDD; Group 2; n=146). In both trials, fatigue was measured with the question to pts: “I feel fatigued” over the past week (5-point rating scale, not at all-very much), and with the provider-rated Common Terminology Criteria for Adverse Events (CTCAE). In addition to descriptive profiles, Study 1 used two modeling approaches; repeated measures model (M1), with time as a categorical predictor; and random intercept-slope model (M2), with time as a continuous predictor. Study 2 calculated mean absolute values of within-cycle rate of change (from one assessment to the next) through the first 6 treatment cycles. Results: In Study 1, representing fatigue across cycles, M1 showed that the initial increase in patient-reported fatigue was worst during Cycle 1; mean values at all subsequent cycles were numerically better. For CTCAE fatigue, M1 showed that all but one of the pair-wise comparisons of the cycle means were not significantly different. M2 showed that the overall trend for patient-reported fatigue and CTCAE fatigue was not statistically different from zero. In Study 2, the mean absolute rate of change for fatigue during 6 treatment cycles was greater for Group 1 (4/2) compared to Group 2 (CDD): 0.042 vs. 0.032, respectively; P=0.003, t-test. Conclusions: In Study 1, pts reported notable fatigue in Cycle 1, which improved or stabilized, thereafter. In Study 2, Schedule 4/2 was associated with more within-cycle fluctuation in fatigue. These findings illustrate how SU-associated fatigue occurs early in therapy and continues with more within-cycle fluctuation associated with 4/2 dosing. This may help patient-clinician communications and interventions that support maintaining effective therapy.

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