Treatment as Prevention ANRS 12249
South Africa, 2012 - 2016
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Reference ID
ANRS12249TasP
Producer(s)
Dabis, François, Newell, Marie-Louise, Pillay, Deenan
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Metadata
Created on
Jan 30, 2018
Last modified
Jan 30, 2018
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- Data files
-
HIV Drug
Treatments - Households
- CHEs
-
Lab Test
Results -
ARTemis Lab
Results -
ARTemis
Patients -
CHE Adverse
Events - SCBs SCCs
-
CHE Action
Plans - Clusters
- Visits
- HHIs
- CFUs
- CFU Pill Tests
- Local Areas
- Census Rounds
- SCIs
-
Individual
Consents -
SAEs Initial
Notifications -
SAEs Initial
Notifications -
Events details -
SAEs Initial
Notifications -
Medications -
SAEs
Complementary
Notifications -
SAEs
Complementary
Notifications -
Medications - CBCs
- Specimens
- IQs
-
Minority
Variants - BMQ Surveys
- NGS Genomics
- Refusals
- NgsAssembQuality
- Sample Genomics
- Locations
- LinkToCareTracker
- Exits
-
ACCDB
Encounters -
ACCDB Encounter
Therapies - Individuals
- Trial Statuses
- DBS results
According to the physician, is this SAE related to any causes other than the research? If yes, describe (SAECausedByOtherDesc)
Data file: SAEs Complementary Notifications
Overview
Valid:
101
Type:
Discrete
Width:
244
Range:
-
Format:
character
Questions and instructions
Categories
| Value | Category | Cases | |
|---|---|---|---|
| 2016/03/17 | 1 |
1%
|
|
| Abdominal TB | 1 |
1%
|
|
| Abnormal LFT's present at baseline. | 1 |
1%
|
|
| Abnormality presental baseline but has gotten worse | 1 |
1%
|
|
| Acuretic therapy for congestive cardiac failure resulting in hypernatremia and acute renal failure. | 1 |
1%
|
|
| Acute Gastroenteriitis | 1 |
1%
|
|
| Acute gastro enterijtis resulting in Pre renal failure exacerbated by zencfair. Patient not fully treated in death. | 1 |
1%
|
|
| Acute gastroentents Pulmonary TB | 1 |
1%
|
|
| Advance HIV desease. | 1 |
1%
|
|
| Anaemia of chronic decease | 1 |
1%
|
|
| Anaemia secondary to menorrhagia | 1 |
1%
|
|
| Bacterial meningitis | 1 |
1%
|
|
| Cause of renal failure was drug TDF, he was on this prior to inclusion in the study | 1 |
1%
|
|
| Drug induced liver injury from TB | 1 |
1%
|
|
| Due to multiples PTB. Post TB bronchrectesis can be an expected complication. | 1 |
1%
|
|
| First frimester miscarriages are very common | 1 |
1%
|
|
| Gallstones were found to be the cause of the patient condition. She jis well post opetration. | 1 |
1%
|
|
| Hypertensive/ccf/ chronic renal failure | 1 |
1%
|
|
| Hypokalaemic cardial arrest. 2 Arrythmia hypokalatmia no Diuretic therapy. | 1 |
1%
|
|
| Immunocompromised , so at risk of abscess. | 1 |
1%
|
|
| Immunosupressed patient sugestable to meningitis | 1 |
1%
|
|
| Initially on TDF/3TC/EFV from 10/08/2012 before switching to Atripla on 08/05/2013 | 1 |
1%
|
|
| Joined the trial already on TDF/FTC/EFV | 1 |
1%
|
|
| MDR-TB | 1 |
1%
|
|
| Menorrhagia causing iron deficiency anaemia. | 1 |
1%
|
|
| Missing | 18 |
17.8%
|
|
| Orolabial herpes simplex | 1 |
1%
|
|
| Participant PRE-ART therefore sugectable to TB MDR - TB highly prevalant in subdiscrict. | 1 |
1%
|
|
| Participant ages + immune status are risk factor for cancer. | 1 |
1%
|
|
| Participant clinically very ill. With low CD4 and malnutrition - highly suspectible to Tubercolosis. | 1 |
1%
|
|
| Participant defaulted his anti convulsants & therefore at risk of siecures | 1 |
1%
|
|
| Participant died due to severe diarrhoea following herbal enema. She was still awaiting ultrsound to determine cause of elevated liver enzymes. | 1 |
1%
|
|
| Participant had TB symptoms at baseline | 1 |
1%
|
|
| Participant had longstanding history of abnormal bleeding. Recurrance of same problem, cause still being investigated. | 1 |
1%
|
|
| Participant with stage IV HIV, also has underlying malnutritious, he is highly suscptible to opportunistic infection | 1 |
1%
|
|
| Participant with treatment failure immunosuppresion may pre-dispose her to malnutrition. | 1 |
1%
|
|
| Participants with co-marbid HIV & TB Having revurrent TB due to poor immunity. | 1 |
1%
|
|
| Patient entered Tasp with renal impliment | 1 |
1%
|
|
| Patient had been lost to follow up for 9 months + defaulted ART before returning already very sick. | 1 |
1%
|
|
| Patient had pulmonary TB + puncytopenia, Continued to deteriorate after stopping AZT. | 1 |
1%
|
|
| Patient has been diagnosed with idiopathic Thrombocytopanic Purpura (Cause unknown) | 1 |
1%
|
|
| Patient immnocompromised at risk of MDR TB | 1 |
1%
|
|
| Patient is a defaulter and ART and HCTZ. He is currently on neither. His renal failure was discovered at baseline, so unlikely due to participation in Tasp. | 1 |
1%
|
|
| Patient was already on ART PRIOR TO JOINING Tasp. | 1 |
1%
|
|
| Patient was assaulted | 1 |
1%
|
|
| Patient was diabetes, hypertension and HIV which all could result in renal failure | 1 |
1%
|
|
| Patient was immunocorpromised +at risk of opportunistic intrection regaless of participant in this trial. | 1 |
1%
|
|
| Patient was lost to following up + severely immunosupressed | 1 |
1%
|
|
| Patient with advanced dissease a nd severe immunosupptrssion | 1 |
1%
|
|
| Patient with co-morbid HIV and TB not improving with treatment, suspected resistance TB | 1 |
1%
|
|
| Patient with declining CD4 count + malnutrition | 1 |
1%
|
|
| Patient with very law CD4 count, susceptible to oppotunistics infection | 1 |
1%
|
|
| Pervic mass , requires further investigation | 1 |
1%
|
|
| Physical assault | 1 |
1%
|
|
| Poorly controlled BP leading to stroke . | 1 |
1%
|
|
| Pre-renal failure from Acute gastroenteritis may have been exacerbated by tenofovir + hydrochochlord thiazide. | 1 |
1%
|
|
| Presumptive Pulmonary Tuberculosis | 1 |
1%
|
|
| Probable Pulmonary Tb - Not culture proven . | 1 |
1%
|
|
| Probable pulmonary tubercolosis | 1 |
1%
|
|
| Psychosis may be due to diseminated tubecolosis | 1 |
1%
|
|
| Pt severely ill with co morbid Mor-TB and advanced HIV disease. She has pur social circumtance and poor nutrition | 1 |
1%
|
|
| Pulmonary TB | 2 |
2%
|
|
| Pulmonary Tb Advanced HIV Infection | 1 |
1%
|
|
| Pulmonary tuberculosis | 1 |
1%
|
|
| Putient at risk of ITP regadless of participant in resech | 1 |
1%
|
|
| Renal failure was present at baseline. The patient is immunocompromised with high rish of oppotunist infection. | 1 |
1%
|
|
| See intiel SAE notification | 1 |
1%
|
|
| Short duration of psychosis supports brief psychotic disorder. Patient now on TDF/3TC/Efv-no recurrence of symptoms | 1 |
1%
|
|
| Shortness of breath,probably had some respiratory problem. | 1 |
1%
|
|
| Stabbed abdomen | 1 |
1%
|
|
| Stroke due to poor controlled BP - Poor compliance | 1 |
1%
|
|
| TB dicease | 1 |
1%
|
|
| The patient has renal failure at baseline entry into the trial. The cave of renal failure news to be investigated further. | 1 |
1%
|
|
| The patient is Immunocompromised and at risk of gastronentetris (which caused dehydration + subsequent renal impaired) | 1 |
1%
|
|
| The patient is very immunocompromised and at risk of opportunistic infections | 1 |
1%
|
|
| The patient suffered gastroentertis, which canned renal failure. After rehydration she now has grade 2 hypercreatinineamia | 1 |
1%
|
|
| The patient was at risk of anaemia + renal failure regardless of participation in research. | 1 |
1%
|
|
| The patient was at risk of opportunistic infection due to HIV | 1 |
1%
|
|
| The patient was severely immunocompromised and malnourished | 1 |
1%
|
|
| The putrent is immunocompromised high rish of opportunist infections. | 1 |
1%
|
|
| This appears to be long -studying confussion prior to entry to Tasp. He has now been transfer back to government health care | 1 |
1%
|
|
| This patient was severely immunocompromised | 1 |
1%
|
|
| idiopathic htrombocytopaemic purpura ,abnormal blood results predated enrollment trial. | 1 |
1%
|
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.