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Treatment as Prevention ANRS 12249 - datasets for Lancet HIV pain paper

South Africa, 2012 - 2016
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ANRS12249TasP.3ie.main.paper
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Dabis, François, Newell, Marie-Louise, Pillay, Deenan
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TasP ANRS 12249
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Jan 30, 2018
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Feb 02, 2018
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According to the physician, is this SAE related to any causes other than the research? If yes, describe (SAECausedByOtherDesc)

Data file: SAEs Initial Notifications

Overview

Valid: 213
Type: Discrete
Width: 244
Range: -
Format: character

Questions and instructions

Categories
Value Category Cases
Abdominal LFT's present at baseline. Patient is also hepertitis B POSITIVE. 1
0.5%
Abnormality present at baseline 1
0.5%
Accident 1
0.5%
Acute cholecystitis,abdonrmal liver function test was present prior to enrolment. 1
0.5%
Acute gastro enteritis causing Pre-renal failure, exacerbated by tenofavir. 1
0.5%
Adequate information on circumstance of death not available. 1
0.5%
Advance HIV Multy-Drug resistant TB 1
0.5%
Advanced HIV 1
0.5%
Advanced HIV + Poor ART Adherence resulting in probable Pulmonary TB. 1
0.5%
Advanced HIV dicease 1
0.5%
Advanced HIV diseased with suspected pulmonary TB 1
0.5%
Advanced HW in patient who interrupted treatment on multiple occasion 1
0.5%
Advanced retroviral dicease at baseline clinic visit. 1
0.5%
Alcohol abuse, present at baseline 1
0.5%
Anaemia of chronic decease 1
0.5%
Anaemiawas noted on baseline blood results 1
0.5%
Anemia of Chronic disease 1
0.5%
Any patient is at rish of being involved in an accident, regardless of partipant in research 1
0.5%
Any patient is susceptible to mentakl health illness or to commit suicide. It does not appear that the trial was related to this event. 1
0.5%
Anybody is at risk of psychiatric illness. More information will follow once patient isd reviewed + diagnosis elicited. 1
0.5%
Baseline revealed Hepatitis BsAg positive . Further information not available 1
0.5%
CA Cervix predated enrolment in Trial 1
0.5%
Cancer of the cervix 1
0.5%
Cause of death is unclear 1
0.5%
Cause of death unknown.Patient reported to have been unwell. 1
0.5%
Cause of severe abdominal pain & vomitting still being investigeted. 1
0.5%
Cellulitis present at baseline clinic visit 1
0.5%
Chronic GI Problem-need futher investigation (different diagnosis bowel TB,paitsistic infection malicvancy) 1
0.5%
Chronic lung deceases - Sequela of Previous TB decease 1
0.5%
Complication of breast feeding 1
0.5%
Decompensated Alcoholic liver dicease with cirrhosis. 1
0.5%
Diagnosis unknown . Patient has only been seen once at baseline . 1
0.5%
Diarrhoea resulting in acute renal failure. Deep vein thrombosis 1
0.5%
Discharged on fluconazole , Probably for hyptococcal meningitis . Will need confirmation . 1
0.5%
Elevation of GGT/LFTs was already present at baseline 1
0.5%
First trimaster miscarriages are very common 1
0.5%
First trimester miscariage 1
0.5%
From relatives. Patient seemed tohave been unwell, resulting in admission of death. 1
0.5%
GGT started rising whilst patient was on D4T/3TC/EFV before joining the research . 1
0.5%
GGT was adnormal at baseline but has gradually gotten worse, starting on Atripla/ Herbal remedies/ alcohol. 1
0.5%
Gall stones 1
0.5%
Gastroenteritis 1
0.5%
HIV opportunistic inffection 1
0.5%
HIV patient on ART's anol PTB treatment 1
0.5%
HIV positive patient,l on Art - susceptible to TB MZDR. TB highly prevalant in subdistrict 1
0.5%
Had Menorrhagra dummy the last Menstrual period. 1
0.5%
Has been I Tasp on Atripla sine 2013 withat prior advvese events . Deranged LFT likely due to an extenal case . 1
0.5%
High risk of malnutrition due to immunosuppression 1
0.5%
High viral load despite prolong ARV use , amotype slims resistance to EFV and 3TC . 1
0.5%
Hiluly to be related to alcohol consumption 1
0.5%
History Incomplete 1
0.5%
Iron deficiency anaemia, cause not yet identified. 1
0.5%
Known HPT/CCF/Chronic renal failure 1
0.5%
LFT's including GGT with grade 3 abnormalities at baseline due to alcohol abuse. 1
0.5%
LT Upper Zone PNeumonia , To Exclude Pulmonary TB Peptic ulcer disease . 1
0.5%
LTS's abnormal at baseline synerstic synergistic toxiaty from Atripla + Alcohol + herbal remedies 1
0.5%
Likely to be worsering curonic kidney Disease due to Hypertension but coud Also be HIV - Associated Nepuropathy . 1
0.5%
Lower Respiratory Trect Infection 1
0.5%
Most likely cause of deranged LFT is alcohol. 1
0.5%
Multiple ART defaults, cannot exlude bone narrow suppression from Cotrimaxazole 1
0.5%
Multy-Drug resistant treatment. 1
0.5%
Normocytic anaemia, requires further investigation. 1
0.5%
Not enough information 1
0.5%
Not on ART in Control cluster and not eligible for ART but returned after 6months and found eligible under new guidelines. Currently not on ART. 1
0.5%
Participant already had TB symptoms at baseline. 1
0.5%
Participant default ed flucconazole, at rist of recurrent cryptococcal meningitis 1
0.5%
Participant defaulted anti - epileptic treatment and thus had siezures 1
0.5%
Participant diagnosis with throat cancer 1
0.5%
Participant found to be Anaemia at baseline visit. 1
0.5%
Participant had dirrhoea, admitted use of herbal medicines and had been nephrotoxic medication. 1
0.5%
Participant had stroke at a young age. She is still undergoing investigation. HIV stroke may be contributing 1
0.5%
Participant has Malnutrion and severe wasting with low CD4 count. He is highly susceptible to infections 1
0.5%
Participant has cervical cancer 1
0.5%
Participant has history of alcohol abuse which is likely to account for raised liver enzymes. 1
0.5%
Participant is hypertensive - risk of renal failure is high. Nephrotoxic treatment also may add to severity 1
0.5%
Participant most likely has iron deficiency anaemia 1
0.5%
Participant newly diagnosed with PTb May have disseminated TB strong hstory of cannibis use 1
0.5%
Participant severely immunosuppressed with PTB. Exact cause of death not yet known. 1
0.5%
Participant surely immunocompromised upon enrolment. Supected TB IRIS. 1
0.5%
Participant susceptible to TB due to immunosuppression. 1
0.5%
Participant unknown with Bipoal mood disorder - is prone to relapsed acute episodes. 1
0.5%
Participant using herbal medicines for Sangoma initiation. At risk of nephiotoxity 1
0.5%
Participant was assaulted 1
0.5%
Participant will longstanding history of severe illness, failed to go to hospital with cormobid HIV and extrapulmonary TB. 1
0.5%
Participant with advances HIV and TB. Needs to be invesitgated to exclude dissiminated or resistant TB. 1
0.5%
Participant with declining CD4 count very suscetible to oppotunistic infections. 1
0.5%
Participant with evidence of treatment failure, no clinical improvement. Has co-morbid TB and HIV. Very ill. 1
0.5%
Participant with history of incorrect dosing of ART. Also previously on NVP which may caused liver toxicity. 1
0.5%
Participant with uncontrolled diabetes , at risk of renal failure 1
0.5%
Participant with very low CD4, not on ART, developed acute renal failure from diarrhoea. 1
0.5%
Participants was injured 1
0.5%
Participantwith very low CD4 succeptable to oppotunisic infections. 1
0.5%
Partiocipant succestible to TB due to immunosuppresion. 1
0.5%
Patient ART naïve and not prescribed any drugs within trial 1
0.5%
Patient LFT's are demaged at baseline entry into TasP 1
0.5%
Patient at risk of cancer regardless of participation in research 1
0.5%
Patient at risk of diarrhoea as imnosuppressed and on Aluvia. Unrelated to research 1
0.5%
Patient committed suicide, the reason for thi is unknown. 1
0.5%
Patient complained of weight loss and dry cough recently . 1
0.5%
Patient developed panariatitis most likely from an acute which is still being investigated. 1
0.5%
Patient developes severe diarrhoea and Acute renal failure prior to Atripla Reveles by blood test done on same day started Atripla. Atripla could have exacerbated the acute renal failuere 1
0.5%
Patient did not go to hospital when referred. She most likely had TB. 1
0.5%
Patient died in his sleep cause unknown. 1
0.5%
Patient extremely immunosuppressed 1
0.5%
Patient had been on ART fkor long period of time before having psychotic episode. 1
0.5%
Patient had breast cancer the trial unfortunately it has progressed 1
0.5%
Patient had deranged LFT prior 0to TasP likely alcohol is the main contributor 1
0.5%
Patient had longstanding history of abdnormal bleeding and had defaulted ART. 1
0.5%
Patient had longstanding history of undiagnored depression which complicated with psychosis 1
0.5%
Patient had variable blood sugar readings over time at Tasp clinics. Was at risk of type 2 diabetes. 1
0.5%
Patient has been to Tasp for 9 months. Only returned now as he is sick. 1
0.5%
Patient has multiple myeloma + on naproxen 1
0.5%
Patient has multiple risk factors for derange LFT's. 1
0.5%
Patient immuno 1
0.5%
Patient immunocompromised . At rish of multiple causes of confusion . 1
0.5%
Patient immunosuppressed, prone to apportunities infections. 1
0.5%
Patient is HIV POSITIVE WITH CHRONIC ANAEMIA. Need amement 1
0.5%
Patient is HIV positive, on ART prior to Tasp. Came of LFT deranged unclear ar present. 1
0.5%
Patient is diabetic,hypertensive and HIV positive which mascles him susceptible to multiple infections. 1
0.5%
Patient is imiunocompromised +atrisk of infection 1
0.5%
Patient is immcompromised with incresed risk of gastroentritis. Risk of dehydration is high with gastroentrities 1
0.5%
Patient is immnocompromised. At risk of TB 1
0.5%
Patient is immnosupressed, At risk of GE 1
0.5%
Patient is severely immunocompromised + at risk of abcsess 1
0.5%
Patient most likely had prostate cancer. PSA was 57 and patient was symptomatic 1
0.5%
Patient must have suffered from dehydrated to vomiting exacerbated by tenofavir + hydrocithorothiazide 1
0.5%
Patient must likely had cervical cancer 1
0.5%
Patient newly diagnosed with TB. She is 1
0.5%
Patient severely ill with co-morbid MDR-TB and advanced AIDS desease 1
0.5%
Patient transfered in at baseline with Hb 6.1 1
0.5%
Patient transferred in with this problem. 1
0.5%
Patient was already on TDF which could be a cause orcontributing factor to this renal failure, fixed doze ARV's stopped. 1
0.5%
Patient was already on antiretroviral drug before joining the research . 1
0.5%
Patient was immnocompromised + side at entry into the trial 1
0.5%
Patient was immunocompromised and known to Abuse alcohol . 1
0.5%
Patient was immunoconipromised with a possible TB ccontact, so was high risk of TB 1
0.5%
Patient was known with congestive cardiac failure. He had defaulted treatment and not disclosed to trail clinic 1
0.5%
Patient was on long term asprin prior to Tasp study. 1
0.5%
Patient was severely immunocompromised. Alluvia can cause diarrhoea, but patient was complinity of diarrhoea before switching to Alluvia. 1
0.5%
Patient with PTB, succeptable to superimposed bacterial infection 1
0.5%
Patient with advances HIV, poor compliance and pulmonary TB 1
0.5%
Patients age and immune status are risk factors fo cancer. 1
0.5%
Pelvic inflammatory disease 1
0.5%
Physical /Sexual Assault 1
0.5%
Pnevious TB Episodes ( 2007/2008 ) 1
0.5%
Poor adherence to ART mth multiple stops restarts possibly IRIS 1
0.5%
Possibly a combination of Stavudine treatment , Alcohol and Hepatitis B . 1
0.5%
Possibly related to Advanced HIV infection. Patient also anemic with weight loss. 1
0.5%
Pre - existing abnormality in YGT, Whilst on D4T/3TC/EFV. Need to obtain alcohol history. 1
0.5%
Predated the reseach . 1
0.5%
Present at baseline with renal failure. Post discharge drug will be ratranalised 1
0.5%
Present at baseline. 1
0.5%
Previous TB,possibly bronchiectasis.Alcohol abuse. 1
0.5%
Probable Iron deficiency Anaemia 1
0.5%
Probable Iron deficiency anemia present at baseline 1
0.5%
Probable Pulmonary TB 1
0.5%
Probable iron Defigency Anaemia 1
0.5%
Probable iron deficiency.Anaemia 1
0.5%
Probable iron definancy anaemia presental baseline 1
0.5%
Probably Haemorrhoids 1
0.5%
Probably alcohol abuse although HAART can cause elevate GT . 1
0.5%
Probably alcohol abuse. 1
0.5%
Probably alcohol related elevation of gamma glutamyl transference.Efavirenz was prescribed before participation in reseach. 1
0.5%
Probably iron deficientcy Anaemia 1
0.5%
Probably iron deficiency anaemia. 1
0.5%
Probably related to Alcohol abuse 1
0.5%
Propable TB,L Presented of baseline 1
0.5%
Pt had familly CD4 count and cough she may have had TB which was not investigated. She also had social stressor. 1
0.5%
Pt on ART for a long time. Confusion is acute with PTB being diagnosed. C7 brain is important to exclude space occupying lesion in the brain 1
0.5%
Pt with multiple episode pulmonary TB susceptible to dyspnoea due to lung fibrosis 1
0.5%
Pt with underlying autommune disease . She recovered quickly from psychosisdespite not being on treatment & is still on Atripla . 1
0.5%
Pulmonary TB 4
1.9%
Rirely due to taking tenofovir , which she commenced prior to enrolling at TASP . No previus renal past medlet history 1
0.5%
Severe diarrhoea and renal failure pre - dated baseline clinic visit. Severe diarrhoea must have resulted in Pre renal failure with additional neuphrotixicty from Tinofavir 1
0.5%
Severe gastroenteritis resulting in acute renal failure exacerbated bytenofovir prescribed before joining trisil 1
0.5%
Stabbed abdomen 1
0.5%
Stroke 1
0.5%
Tdhis patient is Immnocompromised would have been at risk of pneumonia / sepsis regarden of participant in Tasp. 1
0.5%
The parent had proven pulmonary tuberculosis 1
0.5%
The patient died of a presumed urinary truck infetion cammy sepsis,although she was not referred for past- mortem 1
0.5%
The patient has HIV and is at risk of opportunistic infections. 1
0.5%
The patient is at risk of gastroentertis due to immunoconipromise 1
0.5%
The patient was already on TB treatment prior to enrolment in TasP. 1
0.5%
The patient was imminospprened and at risk of oppotunistic infection. 1
0.5%
The patient was immonoscomposed and at risk of aopportunist infection. 1
0.5%
The patient was immunosuppressed and at risk of infection 1
0.5%
The patient was on D4T prior to Tasp but started TDF April 2013 + was stable until this point 1
0.5%
The patient was pregnant + at risk of complaications in research. 1
0.5%
The putient was aneemia before entry into Tasp. Women with HIV are at high risk of cervical cancer 1
0.5%
This patient had HIV and hypertension. Participation is research did not alter the cure 1
0.5%
This patient had microcytic anaemia prior to joining TasP + was investigated for fibrods 1
0.5%
This patient is immnosupressed + at risk of TB + fustro enteritis regardless of participant in Tasp. 1
0.5%
This patient joined Tasp already pregnant + anaemia 1
0.5%
This patient was immunocumpoused and at rsk of TB or TB IRIS 1
0.5%
This patient was killed. There is no relation to this research 1
0.5%
This putient came into the trial with this problem . 1
0.5%
This putient is severely immunosuppressed and prior to hospitaliseted was Art naïve which put him at risk of these events 1
0.5%
Thyroat cancer 1
0.5%
Treatment interruption advanced HIV 1
0.5%
Unable to comment 1
0.5%
Uterine Prolapse coused Hospitalisation for a hysterectomy 1
0.5%
advanced HIV desease tuberculosis 1
0.5%
other differential diagnoses under investigation. Has risk factors for cerebral vascular disease 1
0.5%
patient had diarrhoea for 1 month which could account his renal impaitment . 1
0.5%
patient in immunocompromised . At risk of Infection 1
0.5%
patient is immunocompromised at rish of infection + abscesses 1
0.5%
patient is known to drink alcohol to excn . This is unrelated to the trial 1
0.5%
severe hypochronic anemia 1
0.5%
the patient is immunocomromised and at risk of gastiventertis 1
0.5%
unable to comment 1
0.5%
Warning: these figures indicate the number of cases found in the data file. They cannot be interpreted as summary statistics of the population of interest.
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