Treatment as Prevention ANRS 12249, phase 1
South Africa, 2012 - 2014
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Reference ID
ANRS12249
Producer(s)
Dabis, François, Newell, Marie-Louise
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Created on
May 06, 2014
Last modified
Jan 19, 2015
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- Data files
- DBS Results
-
HIV Drug
Treatments - Households
- CBCs
- CHEs
-
Lab Test
Results -
ARTemis Lab
Results -
ARTemis
Patients -
CHE Adverse
Events - Specimens
-
Individual
Consents - SCBs SCCs
- iDART
-
CHE Action
Plans - Locations
- Clusters
- Trial Statuses
- Visits
- HHIs
- SCIs
- CFUs
- CFU Pill Tests
-
SAEs Initial
Notifications -
SAEs Initial
Notifications -
Events details -
SAEs Initial
Notifications -
Medications -
SAEs
Complementary
Notifications -
SAEs
Complementary
Notifications -
Medications - Individuals
- IQs
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:
69
Type:
Discrete
Width:
244
Range:
-
Format:
character
Questions and instructions
Categories
| Value | Category | Cases | |
|---|---|---|---|
| Abnormality present at baseline | 1 |
1.4%
|
|
| Accident | 1 |
1.4%
|
|
| Acute cholecystitis,abdonrmal liver function test was present prior to enrolment. | 1 |
1.4%
|
|
| Adequate information on circumstance of death not available. | 1 |
1.4%
|
|
| Advance HIV Multy-Drug resistant TB | 1 |
1.4%
|
|
| Advanced HIV | 1 |
1.4%
|
|
| Advanced HIV diseased with suspected pulmonary TB | 1 |
1.4%
|
|
| Advanced HW in patient who interrupted treatment on multiple occasion | 1 |
1.4%
|
|
| Alcohol abuse, present at baseline | 1 |
1.4%
|
|
| Anaemia of chronic decease | 1 |
1.4%
|
|
| Anemia of Chronic disease | 1 |
1.4%
|
|
| Baseline revealed Hepatitis BsAg positive . Further information not available | 1 |
1.4%
|
|
| CA Cervix predated enrolment in Trial | 1 |
1.4%
|
|
| Cellulitis present at baseline clinic visit | 1 |
1.4%
|
|
| Chronic GI Problem-need futher investigation (different diagnosis bowel TB,paitsistic infection malicvancy) | 1 |
1.4%
|
|
| Chronic lung deceases - Sequela of Previous TB decease | 1 |
1.4%
|
|
| Complication of breast feeding | 1 |
1.4%
|
|
| Diagnosis unknown . Patient has only been seen once at baseline . | 1 |
1.4%
|
|
| GGT started rising whilst patient was on D4T/3TC/EFV before joining the research . | 1 |
1.4%
|
|
| Gall stones | 1 |
1.4%
|
|
| Gastroenteritis | 1 |
1.4%
|
|
| HIV opportunistic inffection | 1 |
1.4%
|
|
| Had Menorrhagra dummy the last Menstrual period. | 1 |
1.4%
|
|
| High viral load despite prolong ARV use , amotype slims resistance to EFV and 3TC . | 1 |
1.4%
|
|
| History Incomplete | 1 |
1.4%
|
|
| Known HPT/CCF/Chronic renal failure | 1 |
1.4%
|
|
| LT Upper Zone PNeumonia , To Exclude Pulmonary TB Peptic ulcer disease . | 1 |
1.4%
|
|
| Likely to be worsering curonic kidney Disease due to Hypertension but coud Also be HIV - Associated Nepuropathy . | 1 |
1.4%
|
|
| Lower Respiratory Trect Infection | 1 |
1.4%
|
|
| Multiple ART defaults, cannot exlude bone narrow suppression from Cotrimaxazole | 1 |
1.4%
|
|
| Multy-Drug resistant treatment. | 1 |
1.4%
|
|
| Normocytic anaemia, requires further investigation. | 1 |
1.4%
|
|
| Patient ART naïve and not prescribed any drugs within trial | 1 |
1.4%
|
|
| Patient complained of weight loss and dry cough recently . | 1 |
1.4%
|
|
| 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 |
1.4%
|
|
| Patient must have suffered from dehydrated to vomiting exacerbated by tenofavir + hydrocithorothiazide | 1 |
1.4%
|
|
| Patient was already on antiretroviral drug before joining the research . | 1 |
1.4%
|
|
| Pelvic inflammatory disease | 1 |
1.4%
|
|
| Physical /Sexual Assault | 1 |
1.4%
|
|
| Pnevious TB Episodes ( 2007/2008 ) | 1 |
1.4%
|
|
| Poor adherence to ART mth multiple stops restarts possibly IRIS | 1 |
1.4%
|
|
| Possibly a combination of Stavudine treatment , Alcohol and Hepatitis B . | 1 |
1.4%
|
|
| Possibly related to Advanced HIV infection. Patient also anemic with weight loss. | 1 |
1.4%
|
|
| Pre - existing abnormality in YGT, Whilst on D4T/3TC/EFV. Need to obtain alcohol history. | 1 |
1.4%
|
|
| Predated the reseach . | 1 |
1.4%
|
|
| Probable Iron deficiency Anaemia | 1 |
1.4%
|
|
| Probable Pulmonary TB | 1 |
1.4%
|
|
| Probable iron Defigency Anaemia | 1 |
1.4%
|
|
| Probable iron deficiency.Anaemia | 1 |
1.4%
|
|
| Probably Haemorrhoids | 1 |
1.4%
|
|
| Probably alcohol abuse although HAART can cause elevate GT . | 1 |
1.4%
|
|
| Probably alcohol abuse. | 1 |
1.4%
|
|
| Probably alcohol related elevation of gamma glutamyl transference.Efavirenz was prescribed before participation in reseach. | 1 |
1.4%
|
|
| Probably iron deficientcy Anaemia | 1 |
1.4%
|
|
| Probably iron deficiency anaemia. | 1 |
1.4%
|
|
| Probably related to Alcohol abuse | 1 |
1.4%
|
|
| Pt had familly CD4 count and cough she may have had TB which was not investigated. She also had social stressor. | 1 |
1.4%
|
|
| Pulmonary TB | 3 |
4.3%
|
|
| 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 |
1.4%
|
|
| Severe gastroenteritis resulting in acute renal failure exacerbated bytenofovir prescribed before joining trisil | 1 |
1.4%
|
|
| Stabbed abdomen | 1 |
1.4%
|
|
| Stroke | 1 |
1.4%
|
|
| Treatment interruption advanced HIV | 1 |
1.4%
|
|
| Unable to comment | 1 |
1.4%
|
|
| other differential diagnoses under investigation. Has risk factors for cerebral vascular disease | 1 |
1.4%
|
|
| severe hypochronic anemia | 1 |
1.4%
|
|
| unable to comment | 1 |
1.4%
|
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.