• Title/Summary/Keyword: Adverse events

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Hypofractionated Radiotherapy for Small-sized Hepatocellular Carcinoma as Salvage Therapy: Sustained Local Control and Safety (작은 크기의 재발성 간세포암에 대한 구제치료로 소분할 방사선치료: 국소 제어율과 안전성)

  • Bae, Sun-Hyun;Park, Hee-Chul;Lim, Do-Hoon;Lee, Jung-Ae;Choi, Moon-Seok;Lee, Joon-Hyoek;Koh, Kwang-Cheol;Paik, Seung-Woon;Yoo, Byung-Chul
    • Radiation Oncology Journal
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    • v.28 no.2
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    • pp.85-90
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    • 2010
  • Purpose: To evaluate the rate of tumor response, local control, and treatment-related complications after hypofractionated radiotherapy for recurrent hepatocelluar carcinoma (HCC) less than 5 cm in size. Materials and Methods: Among the HCC patients who were treated by radiotherapy (RT) between 2006 and 2007 after the failure of previous treatment, a total of 12 patients were treated with hypofractionated RT. The criteria for hypofractionated RT was as follows: 1) HCC less than 5 cm, 2) HCC not adjacent to a critical organ, 3) HCC without portal vein tumor thrombosis, and 4) less than 15% of normal liver volume that irradiated 50% of the prescribed dose. Hypofractionated RT was performed with 50 Gy delivered in 10 fractions, at a rate of 5 fractions per week. The evaluation of tumor response was determined by CT scans performed at 3 months after the cessation of RT, followed by the evaluation of toxicity by Common Terminology Criteria for Adverse Events version 3.0. The median follow-up period after radiotherapy was 18 months. Results: A complete response (CR) was achieved in 5 of 12 lesions (41.7%) at CT performed at 3 months after the cessation, whereas the overall complete response was observed in 7 of 12 cases (58.3%). In-field local control rate was sustained in 83.3% of patients. All patients developed intra-hepatic metastases except for 2 patients. The overall survival rate was 90.0% at 1 year and 67.5% at 2 years, respectively. Three patients developed Grade 1 nausea during RT and 1 patient showed a progression of ascites after RT. There was no grade 3 or greater treatment-related toxicities. Conclusion: Hypofractionated RT for small-sized HCC as a salvage therapy showed a 58.3% CR rate and 83.3% of local control. Fifty Gy administered in 10 fractions of partial liver irradiation is considered as a tolerable dose that does not cause severe complications.

Effects of Topical Moisturizers on the Skin of Healthy Full-term Infants and Toddlers (국소 보습제 도포가 정상 영유아 피부에 미치는 영향에 관한 연구)

  • Hyun, Moo Yeol;Lee, Yonghee;Oh, Won Jong;Yoo, Kwang Ho;Park, Kui Young;Kim, Myeung Nam;Hong, Chang Kwun;Kim, Beom Joon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.41 no.1
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    • pp.63-71
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    • 2015
  • Moisturizers are the most prescribed products in dermatology. Treatment with moisturizers aims to maintain skin integrity and overall well-being by providing a healthy appearance. Moisturizers perform very important functions in baby care; however, there are few studies on the effects of moisturizers on the skin of infants. To investigate the effects of moisturizers on the skin of healthy full-term infants and toddlers, thirty-one healthy, full-term, 6- to 36-month-old infants and toddlers without any dermatologic conditions received moisturizer applied to the whole body except the eyes and diaper area after bathing twice daily for 4 weeks. Clinical assessments were conducted before treatment, immediately after the treatment period, and 1 and 4 weeks after treatment. At all visits, skin hydration, transepidermal water loss (TEWL), skin pH, and skin roughness were measured, the skin surface was photographed, and any adverse events were recorded. After using moisturizer, skin hydration significantly increased and TEWL and roughness significantly decreased. The skin pH was modified to mildly acidic and the skin surface was visually smoother than before treatment. There were no statistical significant differences of effects of moisturizers according to age and sex, and adverse events were not observed. The results of moisturizer application on the skin were increased skin hydration, recovery of barrier function, balancing skin pH within a mildly acidic range, and increasing the smoothness of the skin surface for 4 weeks.

Prognostic Analysis of Drug-Eluting Balloon Catheter and Drug-Eluting Stent for In-Stent Restenosis of Drug-Eluting Stent (스텐트 재협착 병변에서 약물코팅 풍선카테터과 약물용출 스텐트의 예후 분석)

  • Lee, Doo Hwan;Song, Jong Nam;Park, Sin eui;Choi, Nam Gil;Han, Jae Bok;Kim, In Soo
    • Journal of the Korean Society of Radiology
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    • v.13 no.3
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    • pp.381-389
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    • 2019
  • Although the development of Drug-eluting stent (DES) improved the ISR significantly more than the Bare metal stent (BMS), the coronary stent restenosis (ISR) treatment still has a high recurrence rate. This study is compared the efficacy of DEB with that of DES implantation in patients with ISR. Among 4,316 patients who underwent coronary stent implantation at the Chonnam National University Hospital between November 2012 and December 2016, 187 patients developed ISR on follow-up coronary angiography ($66.3{\pm}11.0years$, 123 males) were enrolled and divided into two groups according to revascularization method as group I (DEB group; n=127) and group II (DES group; n=60). Primary end point was defined as major adverse cardiac events (MACEs), composite of cardiac death (CD), myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) during two-year follow-up between the two groups. There were no differences in the baseline characteristics and angiographic findings except that prevalence of device length was shorter ($21.1{\pm}5.3$ vs. $25.3{\pm}9.6 mm$, p<0.002) in group I.Two-year MACE were not different in the two groups (8.7%vs.10.0%, p=0.789). The incidences of cardiac death (0%vs.0%, p=1.000), MI (1.6%vs.6.7%, p=0.085), TLR(8.7% vs. 10.0%, p=0.789) and ST (0% vs. 0%, p=1000). DEB demonstrated comparable risk reduction for MACEs compared with DES in patients with ISR during two-year follow-up. DEB might be good alternative for the treatment of ISR in patients with ISR.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 2024
  • The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

An Open-label, Randomized, Comparative Assessment of the Efficacy and Safety between Tofisopam and Lorazepam in Anxiety Disorder (Tofisopam과 lorazepam의 항불안효과와 안전성에 대한 비교 연구)

  • Lee, Min Soo;Kim, Yong-Ku;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.4 no.2
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    • pp.265-271
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    • 1997
  • Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

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Retrospective Analyses of Long-Term Use of SSRI in Children and Adolescents with Autism Spectrum Disorder (소아청소년 자폐성 스펙트럼 장애에서 SSRI 장기 사용에 대한 후향적 분석)

  • Goo, Ae-Jin;Park, Jin-Park;Lee, Jong-Il;Jhin, Hye-Kyung;Kim, Yeni
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.205-210
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    • 2012
  • Objectives The purpose of this study was to investigate clinical profile, efficacy, and safety of long-term treatment with selective serotonin reuptake inhibitors (SSRIs) in Korean autism spectrum disorders (ASDs) patients. Methods Effectiveness was assessed through a retrospective review of self-reported target symptom improvement at the last follow-up visit. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity (CGI-S) of illness and Clinical Global Impression-Improvement (CGI-I) Scales. Tolerability was assessed through a review of the reason for discontinuation of SSRI and documented adverse events. Results A total of 21 ASDs patients (aged 9 to 19 years) treated with SSRI during July 2010 to July 2011 in department of child and adolescent psychiatry of Seoul National Hospital were identified. The mean duration of SSRI treatment was 47.9 (standard deviation = 36.9) months (range 0.7-114.5), and the mean fluoxetine equivalent dosage of SSRIs was $27.1{\pm}10.8$ mg. Nineteen (90.5%) patients were using concomitant medication. We found that SSRIs were prescribed for symptoms of agitation, stereotyped behavior, aggression, depression, impulsivity and self-injury in ASDs. Ten patients (47.6%) reported improvement in their target symptom after SSRI treatment based on CGI-I scores (CGI-I ${\leq}$ 2). The side effects were reported in 5 patients (23.8%) ; vomiting (n = 2, 9.5%), excessive mood elevation (n = 1, 4.8%), insomnia (n = 1, 4.8%), somnolence (n = 1, 4.8%) and decreased appetite (n = 1, 4.8%). Self-injurious behavior was reported in one patient (4.8%). Conclusions The results of this study suggest that SSRIs may be used effectively in children and adolescents diagnosed with ASDs. However, safety issues need to be considered carefully when choosing SSRIs for treatment. Future controlled trials are needed to confirm these findings.

Guideline of Improvement and Evaluation of Prescribing Errors in Colorectal Chemotherapy (대장암 항암 화학요법의 처방 오류 평가 및 개선안 제시)

  • Lim, Hyun-Soo;Lim, Sung Cil
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.2
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    • pp.158-166
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    • 2013
  • Background: Colorectal cancer shows a significant increase in South Korea due to westernization of diet, lack of dietary fiber, drinking and smoking, irregular defecation. There are surgery, chemotherapy, radiation therapy in treatment of colorectal cancer. There may be a medication errors in the process of chemotherapy because of its high toxicity, narrow therapeutic index and the health status of cancer patients. Consequently medication errors can cause increasing the risk of death, prolonging hospital stay and increasing the cost. Among medication errors on medication use process, prescribing errors are of particular concern due to higher risk of serious consequences. It is important for pharmacist to prevent the prescribing errors before reaching patient. Therefore we analyzed the prescriptions of colorectal cancer, classified prescribing errors, suggested guideline to reduce prescribing errors and verified the importance of pharmacist's role in prevention of medication errors activity. Methods: We collected the numbers of prescriptions of colorectal cancer(n=2,373) through anti cancer management program and EMR and analyzed the errors of prescriptions by categories from Oct 1st 2011 to Sep 30th 2012 at Chungbuk National University Hospital. We reviewed the prescriptions as follows - patients' characteristics, the result of test, previous prescriptions, characteristics of antineoplastic agents and patients' allergy, drug sensitivity, adverse events. Prescriptions are classified into inpatient and outpatient and analyzed the errors of prescriptions by categories (dosage form, dose, input, diluents, regimen, product). Results: Total prescription number of inpatient and outpatient of colorectal cancer was 1,193 and 1,180 and that of errors was 107(9%) and 22(1.9%), respectively. In case of errors of categories, the number of errors of dosage form is 69 and 8, errors of dose is 15 and 5, errors of input is 9 and 9 in inpatient and outpatient prescriptions, respectively. Errors of diluents is 8, errors of regimen is 3, errors of product is 3 in only inpatient prescriptions. In case of errors of categories by inpatient department, the number of errors of dosage form is 34 and 35, errors of dose is 7 and 8, errors of input is 6 and 3, errors of diluents is 4 and 4, errors of regimen is 2 and 1, errors of product is 2 and 1 in SG and HO, respectively. In case of outpatient department, the number of errors of dosage form is 8 in HO, errors of dose is 5 in HO, errors of input is 5 and 4 in SG and HO, respectively. Conclusions: The rate of errors of inpatient is higher than that of outpatient. Junior doctors are engaged in prescriptions of inpatient and pharmacist need to pay attention to review all prescriptions. If prescribing errors are discovered, pharmacist should contact the prescriber and correct the errors without delay. The guideline to reduce prescribing errors might be upgrading software of anti cancer management program, education for physicians as well as pharmacists and calling prescriber's attention to preventing recurrence of errors.

A Comparative Study on the Clinical Efficacy and Safety between Combination Therapy with CDK 4/6 Inhibitor and AI Versus AI Monotherapy in HR+/HER type2- Advanced Breast Cancer: Updated Meta-analysis (메타분석을 이용한 호르몬 수용체 양성/인체 상피세포 성장 인자 수용체 음성 진행성 유방암에서 사이클린 의존성 인산화효소 4/6 억제제와 방향화효소 억제제 병용요법과 방향화효소 억제제 단독요법의 임상적 유효성 및 안전성 비교 연구)

  • Kim, Min Ji;Kim, Kyung;Cho, MoonKyoung;Sohn, KieHo;Baek, In-hwan
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.1-10
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    • 2020
  • Objective: The aim of the study was to perform a meta-analysis of randomized clinical trials to compare the clinical efficacy and safety between combination of cyclin-dependent kinase (CDK) 4/6 inhibitors with aromatase inhibitors (AIs) and AIs alone in patients with hormone receptor+/human epidermal growth factor receptor type2-(HR+/HER2-) advanced breast cancer. Methods: Published clinical studies were identified through electronic database searches until February 2019. Literature qualities were assessed by the Scottish Intercollegiate Guidelines Network Checklist. Key endpoints of efficacy were progression-free survival (PFS), objective response rate (ORR), and clinical benefit (CB). Endpoints of safety were adverse events (AEs) (neutropenia, leukopenia, any grade 3/4 AEs, and serious AEs) and on-treatment death. Meta-analysis was performed using the RevMan 5.3 software. Results: The selected five studies were evaluated as "good" in quality assessment. Compared to AIs alone, the combination therapy significantly improved PFS (pooled hazard ratio=0.55; 95% confidence interval (CI) 0.49-0.62), ORR (odds ratio=1.78; 95% CI=1.49-2.13), and CB (odds ratio=1.86; 95% CI=1.51-2.28). The prevalence of AEs was significantly higher in the combination group than in the AIs alone group. On-treatment death was greater in the combination group than in the AIs alone group, although insignificant. Conclusion: The combination therapy of CDK4/6 inhibitors with AIs was more effective for the treatment of HR+/HER2- advanced breast cancer, but less safe than AIs alone. The combination therapy should be effectively managed through patient monitoring, and further studies are needed to reduce AEs in the combination therapy of CDK4/6 inhibitors with AIs.

Inter-Facility Transport on Extracorporeal Life Support: Clinical Outcomes and Comparative Analysis with In-house Patients

  • Hong, Tae Hee;Lee, Heemoon;Jung, Jae Jun;Cho, Yang Hyun;Sung, Kiick;Yang, Ji-Hyuk;Lee, Young-Tak;Cho, Su Hyun
    • Journal of Chest Surgery
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    • v.50 no.5
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    • pp.363-370
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    • 2017
  • Background: Extracorporeal life support (ECLS) is widely used in refractory heart or lung failure, and the demand for inter-facility transportation on ECLS is expanding. However, little is known about post-transportation outcomes, the clinical safety of such transportation, or the characteristics of the transported patients. Methods: This was a retrospective review of a 3-year, single-institution experience with inter-facility ECLS transport, as well as a comparative analysis of clinical outcomes with those of in-house patients. We also analyzed the risk factors for hospital mortality in the entire ECLS population using univariate and multivariate analyses to investigate the effects of transport. Results: All 44 patients were safely transported without adverse events. The average travel distance was 178.7 km, with an average travel time of 74.0 minutes. Early survival of the transported group seemed to be better than that of the in-house group, but the difference was not statistically significant (70.5% vs. 56.6%, p=0.096). The incidence of complications was similar between the 2 groups, except for critical limb ischemia, which was significantly more common in the transported group than in the in-house group (25.0% vs. 8.1%, p=0.017). After adjusting for confounders, being part of the transported group was not a predictor of early death (adjusted odds ratio, 0.689; p=0.397). Conclusion: Transportation of patients on ECLS is relatively safe, and the clinical outcomes of transported patients are comparable to those of in-house ECLS patients. Although matched studies are required, our study demonstrates that transporting patients on ECLS did not increase their risk of hospital mortality after adjustment for other factors.

Treatment outcome of hepatic re-irradiation in patients with hepatocellular carcinoma

  • Seol, Seung Won;Yu, Jeong Il;Park, Hee Chul;Lim, Do Hoon;Oh, Dongryul;Noh, Jae Myoung;Cho, Won Kyung;Paik, Seung Woon
    • Radiation Oncology Journal
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    • v.33 no.4
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    • pp.276-283
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    • 2015
  • Purpose: We evaluated the efficacy and toxicity of repeated high dose 3-dimensional conformal radiation therapy (3D-CRT) for patients with unresectable hepatocellular carcinoma. Materials and Methods: Between 1998 and 2011, 45 patients received hepatic re-irradiation with high dose 3D-CRT in Samsung Medical Center. After excluding two ineligible patients, 43 patients were retrospectively reviewed. RT was delivered with palliative or salvage intent, and equivalent dose of 2 Gy fractions for ${\alpha}/{\beta}=10Gy$ ranged from $31.25Gy_{10}$ to $93.75Gy_{10}$ (median, $44Gy_{10}$). Tumor response and toxicity were evaluated based on the modified Response Evaluation Criteria in Solid Tumors criteria and the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0. Results: The median follow-up duration was 11.2 months (range, 4.1 to 58.3 months). An objective tumor response rate was 62.8%. The tumor response rates were 81.0% and 45.5% in patients receiving ${\geq}45Gy_{10}$ and $<45Gy_{10}$, respectively (p = 0.016). The median overall survival (OS) of all patients was 11.2 months. The OS was significantly affected by the Child-Pugh class as 14.2 months vs. 6.1 months (Child-Pugh A vs. B, p < 0.001), and modified Union for International Cancer Control (UICC) T stage as 15.6 months vs. 8.3 months (T1-3 vs. T4, p = 0.004), respectively. Grade III toxicities were developed in two patients, both of whom received ${\geq}50Gy_{10}$. Conclusion: Hepatic re-irradiation may be an effective and tolerable treatment for patients who are not eligible for further local treatment modalities, especially in patients with Child-Pugh A and T1-3.